Recall Z-1607-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.
| Date | Jul 23, 2009 (initiated Apr 16, 2009) |
| Status | Terminated |
| Reason | Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool. |
| Root cause | Process control |
| Action | "Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970. |
| Quantity | 2498 units total, all sizes. |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070095 | TRIATHLON TS KNEE SYSTEM Howmedica Osteonics Corp., Jun 1, 2007 |