Zimmer, Inc. - Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology - Class 1 Recall
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck ...
Source: Medical Device Recalls - June 9, 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
Zimmer Manufacturing B.V. - Trilogy Cups - Class 2 Recall
Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 25, 2014 Category: Medical Equipment Source Type: alerts
Zimmer Manufacturing B.V. - Trilogy Bone Screws - Class 2 Recall
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, ...
Source: Medical Device Recalls - December 18, 2014 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - Persona Stemmed 5 Degree Cemented Tibia - Class 2 Recall
Persona Stemmed 5 Degree Cemented Tibia 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 in which satisfactory stability in flexion cannot be obtained at the time of surgery. T...
Source: Medical Device Recalls - November 9, 2014 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - Zimmer Patellofemoral Joint (PFJ) Prosthesis - Class 2 Recall
Gender Solution Patello-Femoral Joint System Patello-Femoral Trochlea Component, Precoat, Size 4, Left Product Usage: The Zimmer Patellofemoral Joint (PFJ) Prosthesis is designed to closely replicate the anatomic features of the patellar groove on the femur. The implant s articulating surface incorporates the NexGen¿ knee system s frontal profile geometry for optimal patella tracking for both resurfaced and unresurfaced patellae. The construct of the PFJ prosthesis accommodates a wide range of patients, both female and male. Five sizes in left and right configurations are being offered for this implant. Intended...
Source: Medical Device Recalls - August 27, 2014 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - 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
