Recall Z-1013-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; Catalog number 5532-G-713, Catalog number 5532-G-813 Stryker Orthopaedics
| Date | Mar 3, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert Size 8-13 mm) |
| Root cause | Labeling mix-ups |
| Action | Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should |
| Quantity | 9 of lot code LBD528; 14 of lot code LBD512 |
| Distribution | Nationwide Distribution: FL and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051146 | TRIATHLON KNEE SYSTEM Howmedica Osteonics Corp., Jul 13, 2005 |