Drug recall
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head…
FDA recall event 97708 · Class II · Total Joint Orthopedics, Inc.
Key facts
| Event ID | 97708 |
|---|---|
| Recall numbers | Z-0432-2026 |
| Recalling firm | Total Joint Orthopedics, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Sep 23, 2025 |
| Report date | Nov 12, 2025 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 3008544874 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: