Zimmer Manufacturing B.V. - NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat - Class 2 Recall
***LOT***NexGen¿ Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The 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, va...
Source: Medical Device Recalls - June 28, 2014 Category: Medical Equipment Source Type: alerts

Ortho Development Corporation - PSC Femoral Nonporous Rt Sz 6 - Class 2 Recall
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Product Usage: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities. 6. Revision procedures where other treatments or devices have failed. The Balanced Knee¿ System and Balanced Knee¿ Revision System are intended for total knee arthroplasty procedures. The Balanced Knee¿ System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the ...
Source: Medical Device Recalls - May 14, 2014 Category: Medical Equipment Source Type: alerts

Mako Surgical Corporation - Restoris Multicompartmental Knee (MCK) System - Class 2 Recall
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single o...
Source: Medical Device Recalls - March 5, 2014 Category: Medical Equipment Source Type: alerts

Smith & Nephew Inc - Reflection(R) Interfit(TM) Shell, 52 MM OD, 3 HOLE - Class 2 Recall
Reflection(R) Interfit(TM) Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2014 Category: Medical Equipment Source Type: alerts

Zimmer, Inc. - NexGen Complete Knee Solutions Stemmed Tibial Component Precoat - Class 2 Recall
NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 12, 2013 Category: Medical Equipment Source Type: alerts