TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
FDA device recall Z-2462-2026 · posted 2026-06-17 · Open, Classified
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- Reason for recall
- Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
- Action taken
- Stryker notified consignees on about 05/19/2026 via letter sent using FedEx 2-day service. Consignees were instructed to inform users of the Urgent Medical Device Recall and forward the notice to all individuals who need to be made aware or organizations who have consigned product, immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are on hand, and complete and return the provided Urgent Medical Device Recall Business Reply Form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 7 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.
- Date initiated
- 2026-05-19
- Date posted
- 2026-06-17
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIATHLON TRITANIUM TIBIAL BASEPLATE (K123486) | Stryker | 2013-05-03 |