Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head
- Recalling company
- Total Joint Orthopedics, Inc.
- Product
- Brand 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 OD, 28 mm Head; 3205.49.028 Klassic BiPolar Head, 49 mm OD, 28 mm Head; 3205.50.028 Klassic BiPolar Head, 50 mm OD, 28 mm Head; 3205.51.028 Klassic BiPolar Head, 51 mm OD, 28 mm Head; 3205.52.028 Klassic BiPolar Head, 52 mm OD, 28 mm Head; 3205.53.028 Klassic BiPolar Head, 53 mm OD, 28 mm Head; 3205.54.028 Klassic BiPolar Head, 54 mm OD, 28 mm Head; 3205.55.028 Klassic BiPolar Head, 55 mm OD, 28 mm Head; 3205.56.028 Klassic BiPolar Head, 56 mm OD, 28 mm Head; 3205.58.028 Klassic BiPolar Head, 58 mm OD, 28 mm Head; 3205.60.028 Klassic BiPolar Head, 60 mm OD, 28 mm Head
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 23, 2025
- Reported
- Nov 12, 2025
- Distribution
- US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.
- Status
- Ongoing
- Quantity
- 103 units
- Lot / codes
- Part Number/UDI/Lot Number: 3205.41.022 00814703011931 3205.42.022 00814703011948 3205.43.022 00814703011955 3205.44.028 00814703011962 3205.45.028 00814703011979 3205.46.028 00814703011986 3205.47.028 00814703011993 3205.48.028 00814703012006 3205.49.028 00814703012013 3205.50.028 00814703012020 3205.51.028 00814703012037 3205.52.028 00814703012044 3205.53.028 00814703012051 3205.54.028 00814703012068 3205.55.028 00814703012075 3205.56.028 00814703012082 3205.58.028 00814703012105 3205.60.028 00814703012129
- Company location
- Salt Lake City, UT
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0432-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0432-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.