Recall Z-0399-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.
| Date | Feb 8, 2007 (initiated Dec 4, 2006) |
| Status | Terminated |
| Reason | A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa. |
| Root cause | Other |
| Action | Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt. |
| Quantity | 23 units |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051146 | TRIATHLON KNEE SYSTEM Howmedica Osteonics Corp., Jul 13, 2005 |