Recall Z-1231-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
| Date | Sep 25, 2007 (initiated Jul 31, 2007) |
| Status | Terminated |
| Reason | Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post. |
| Root cause | Other |
| Action | Recall notification letters and product acknowledgment forms were send via Federal Express on August 2, 2007. |
| Quantity | 14 |
| Distribution | Product distributed to 5 hospitals in GA, OH, MN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070095 | TRIATHLON TS KNEE SYSTEM Howmedica Osteonics Corp., Jun 1, 2007 |