Brand
Total Joint Orthopedics
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Total Joint Orthopedics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-12FDA-DeviceClass IIBrand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic BiPolar Head, 45 mm OD, 28 mm Head; 3205.46.028 Klassic BiPolar Head, 46 mm OD, 28 mm Head; 3205.47.028 Klassic BiPolar Head, 47 mm OD, 28 mm Head; 3205.48.028 Klassic BiPolar Head, 48 mm O
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
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