Reported Nov 12, 2025 · Ongoing
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head;…
Total Joint Orthopedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Total Joint Orthopedics, Inc. · 1567 E Stratford Ave · Salt Lake City, UT · 84106-3559
Is this the product you have?
- Brand NameKlassic
- BiPolar Head Model/Catalog Number
3205.41.022 Klassic BiPolar Head41 mm OD22 mm Head3205.42.022 Klassic BiPolar Head42 mm OD22 mm Head3205.43.022 Klassic BiPolar Head43 mm OD22 mm Head3205.44.028 Klassic BiPolar Head44 mm OD28 mm Head3205.45.028 Klassic BiPolar Head45 mm OD28 mm Head3205.46.028 Klassic BiPolar Head46 mm OD28 mm Head3205.47.028 Klassic BiPolar Head47 mm OD28 mm Head3205.48.028 Klassic BiPolar Head48 mm OD28 mm Head3205.49.028 Klassic BiPolar Head49 mm OD28 mm Head3205.50.028 Klassic BiPolar Head50 mm OD28 mm Head3205.51.028 Klassic BiPolar Head51 mm OD28 mm Head3205.52.028 Klassic BiPolar Head52 mm OD28 mm Head3205.53.028 Klassic BiPolar Head53 mm OD28 mm Head3205.54.028 Klassic BiPolar Head54 mm OD28 mm Head3205.55.028 Klassic BiPolar Head55 mm OD28 mm Head3205.56.028 Klassic BiPolar Head56 mm OD28 mm Head3205.58.028 Klassic BiPolar Head58 mm OD28 mm Head3205.60.028 Klassic BiPolar Head60 mm OD28 mm Head
- Lot codes and dates
- Part Number/UDI/Lot Number
3205.41.022008147030119313205.42.022008147030119483205.43.022008147030119553205.44.028008147030119623205.45.028008147030119793205.46.028008147030119863205.47.028008147030119933205.48.028008147030120063205.49.028008147030120133205.50.028008147030120203205.51.028008147030120373205.52.028008147030120443205.53.028008147030120513205.54.028008147030120683205.55.028008147030120753205.56.028008147030120823205.58.028008147030121053205.60.02800814703012129
- Part Number/UDI/Lot Number
- Amount recalled
- 103 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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