Recall Z-2461-2026 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
| Date | Jun 17, 2026 (initiated May 19, 2026) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker, May 3, 2013 |