ARCHIBONE (rheumatoid arthritis and osteoarthritis recovery, and cartilage restore) capsule [HCBIOPHARM LLC]
Updated Date: Thu, 18 Aug 2022 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 18, 2022 Category: Drugs & Pharmacology Source Type: alerts

HERBCITI ARCHIBONE (rheumatoid arthritis and osteoarthritis recovery, and cartilage restore) capsule [HerbCiti LLC]
Updated Date: Mon, 22 Nov 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 22, 2021 Category: Drugs & Pharmacology Source Type: alerts

Biomet, Inc. - Custom Cancellous Thread - Class 2 Recall
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2020 Category: Medical Devices Source Type: alerts

Encore Medical, LP - EMPOWR Acetabular System - Class 2 Recall
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts

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

OSTEOARTHRITIS PAIN MANAGEMENT (Horse Chestnut And Ruta Graveolens Flowering Top) Solution/ Drops [Forces Of Nature]
Updated Date: Nov 13, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 13, 2018 Category: Drugs & Pharmacology Source Type: alerts

MicroPort Orthopedics Inc. - MicroPort Orthopedics SCHANZ SCREW SELF DRILL - Class 2 Recall
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed (Sour...
Source: Medical Device Recalls - October 12, 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

OMNIlife science Inc. - OMNI Hip System, ApeXLNK Acetabular Inserts - Class 2 Recall
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobal...
Source: Medical Device Recalls - July 26, 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 l...
Source: Medical Device Recalls - May 22, 2018 Category: Medical Devices Source Type: alerts

Zimmer Biomet, Inc. - PERSONA THE PERSONALIZED KNEE SYSTEM - Class 2 Recall
PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 28, 2018 Category: Medical Devices Source Type: alerts

OMNIlife science Inc. - Apex Knee System - Class 2 Recall
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts

United Orthopedic Corporation - Knee joint replacement - Class 2 Recall
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. T...
Source: Medical Device Recalls - March 20, 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 co...
Source: Medical Device Recalls - March 20, 2018 Category: Medical Devices Source Type: alerts