Recall Z-2360-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface
| Date | Aug 10, 2015 (initiated May 29, 2015) |
| Status | Terminated |
| Reason | Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert. |
| Root cause | Under Investigation by firm |
| Action | Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated July 9, 2015 and Product Accountability Forms via return receipt. The letter identified the affected product, problem, potential hazard, risk mitigation and actions to be taken. Contact Stryker Orthopaedics Sales Representative to arrange for return of the affected product. For questions call 201-831-5826. |
| Quantity | 26 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS Stryker Orthopaedics, Aug 5, 2014 |