Integra Lifesciences Sales Llc - Ascension Silicone PIPSilicone - Class 2 Recall
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2019 Category: Medical Devices Source Type: alerts

Exactech, Inc. - Truliant Tibial Fit Tray - Class 2 Recall
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2019 Category: Medical Devices Source Type: alerts

Stryker GmbH - The Hoffman LRF System - Class 2 Recall
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or soft...
Source: Medical Device Recalls - October 30, 2018 Category: Medical Devices Source Type: alerts

Stryker GmbH - The Hoffman LRF System - Class 2 Recall
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or sof...
Source: Medical Device Recalls - October 30, 2018 Category: Medical Devices Source Type: alerts

Stryker GmbH - The Hoffman LRF System - Class 2 Recall
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or sof...
Source: Medical Device Recalls - October 30, 2018 Category: Medical Devices Source Type: alerts

Stryker GmbH - The Hoffman LRF System - Class 2 Recall
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or sof...
Source: Medical Device Recalls - October 30, 2018 Category: Medical Devices Source Type: alerts

Exactech, Inc. - The OPTETRAK Logic CC Total Knee System - Class 2 Recall
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2018 Category: Medical Devices Source Type: alerts

Orthofix Srl - Double Row Footplates (TLHEX Sterile; All sizes) - Class 2 Recall
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segments aligned during the healing process. The device may only be applied by a physician, who is fully responsible for the surgical and po...
Source: Medical Device Recalls - June 6, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - 5o (degree) GENESIS(R) II VALGUS BUSHING - Class 2 Recall
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or la...
Source: Medical Device Recalls - May 22, 2018 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - LEGION HK FEMORAL WEDGE - Class 2 Recall
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial col...
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts

Exactech, Inc. - Alteon HA Femoral Stems - Class 2 Recall
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions whe...
Source: Medical Device Recalls - January 19, 2018 Category: Medical Devices Source Type: alerts

Exactech, Inc. - Vintage Total Ankle Tibia Insert - Class 2 Recall
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2017 Category: Medical Devices Source Type: alerts

Exactech, Inc. - Vantage Total Ankle Tibia Insert - Class 2 Recall
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2017 Category: Medical Devices Source Type: alerts

Smith & Nephew, Inc. - LEGION LWEDGE - Class 2 Recall
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Componen...
Source: Medical Device Recalls - November 17, 2017 Category: Medical Devices Source Type: alerts

PTSD/STRESS REMEDY (Kali Phosphoricum, Ambra Grisea, Cacao, Lithium Carbonicum, Phosphoricum Acidum, Arnica Montana, Aconitum Napellus, Calcarea Carbonica, Cerebrum Suis, Glandula Suprarenalis Suis, Argemone Mexicana, Arsenicum Album, Cicuta Virosa, Hyoscyamus Niger, Ignatia Tigrinum, Natrum Muriaticum, Tarentula Hispanica, Stramonium, Buthus Australis) Liquid [Deseret Biologicals, Inc.]
Updated Date: Aug 2, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 2, 2017 Category: Drugs & Pharmacology Source Type: alerts

Zimmer Biomet, Inc. - Oxford Fixed Lateral Partial Knee System - Class 2 Recall
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartment...
Source: Medical Device Recalls - January 7, 2017 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Synthes (USA) Products LLC - Titanium Single Vector Distractor Body and Proximal Foot Plate - Class 2 Recall
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Gmbh - Avenir Mller Stem - Class 2 Recall
Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 27, 2016 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Femoral Stems - Class 2 Recall
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation. (Source: ...
Source: Medical Device Recalls - July 6, 2016 Category: Medical Equipment Source Type: alerts

Exactech, Inc. - Femoral Stems - Class 2 Recall
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 6, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hi...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION H...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION ...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION ...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hin...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Smith & Nephew, Inc. - LEGION(TM) HK FEMORAL ASSEMBLY - Class 2 Recall
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION H...
Source: Medical Device Recalls - June 30, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXT GENERATION KNEE SYSTEM - Class 2 Recall
NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexi...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXGEN COMPLETE KNEE SOLUTION LPSFLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONE - Class 2 Recall
CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of prev...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CONIDIUM SURFACE HARDENING PROCESS - Class 2 Recall
NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts ...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)FLEX FEMORAL COMPONENTS - Class 2 Recall
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS - Class 2 Recall
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NexGen Complete Knee Solution MIS Total Knee Procedure Cruciate Retaining CR Flex Mobile Bearing Pre - Class 2 Recall
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - ZIMMER NEXGEN LPSFLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM - Class 2 Recall
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical a...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ART - Class 2 Recall
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of ...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPSFLEX FIXED BEARING FEMORAL AND - Class 2 Recall
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously f...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Zimmer Biomet, Inc. - METASUL TAPER LINERS, METASUL FEMORAL HEADS - Class 2 Recall
Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity an...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts

Biomet, Inc. - Oxford Fixed Lateral - Class 2 Recall
Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are ind...
Source: Medical Device Recalls - July 15, 2015 Category: Medical Equipment Source Type: alerts

Aesculap Implant Systems - Columbus Tibia Plateau (component of the Columbus REVISION Knee System) - Class 2 Recall
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Medacta Usa Inc - EvolisFemoral Sizer Posterior Reference - Class 2 Recall
Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotati...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic - Class 2 Recall
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient ...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bo...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone st...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bo...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Arthrosurface, Inc. - The HemiCAP Contoured Articular Prosthetic; 25&38;30mm 10.5x28mm - Class 2 Recall
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035 The HemiCAP¿ Contoured Articular Prosthetic incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. Indications for Use: For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient ...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts

Stelkast Co - EXp Tibial Insert - Class 2 Recall
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2015 Category: Medical Equipment Source Type: alerts