Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205 — Class II medical device recall Z-0432-2026
Ongoing recall by Total Joint Orthopedics, Inc., reported 2025-11-12, distributed nationwide. Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of
| Recall number | Z-0432-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Total Joint Orthopedics, Inc., Salt Lake City, UT, United States |
| Recall initiated | 2025-09-23 |
| Classified | 2025-11-05 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 103 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00814703011931, 00814703011948, 00814703011955, 00814703011962, 00814703011979, 00814703011986, 00814703011993, 00814703012006, 00814703012013, 00814703012020, 00814703012037, 00814703012044, 00814703012051, 00814703012068, 00814703012075, 00814703012082, 00814703012105, 00814703012129 |
| Lot numbers | 3205.41.022, 3205.42.022, 3205.43.022, 3205.44.028, 3205.45.028, 3205.46.028, 3205.47.028, 3205.48.028, 3205.49.028, 3205.50.028, 3205.51.028, 3205.52.028, 3205.53.028, 3205.54.028, 3205.55.028, 3205.56.028, 3205.58.028, 3205.60.028 |
| Model numbers | 3205.41.022 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0432-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.