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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 LEGI...
Source: Medical Device Recalls - June 30, 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 s...
Source: Medical Device Recalls - February 23, 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, varu...
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 salva...
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 ...
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 ...
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 ...
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 stab...
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 s...
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 pre...
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 ...
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...
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 ro...
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 b...
Source: Medical Device Recalls - February 13, 2015 Category: Medical Equipment Source Type: alerts