Recall Z-1618-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.
| Date | Jul 15, 2009 (initiated May 15, 2009) |
| Status | Terminated |
| Reason | The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect. |
| Root cause | Process change control |
| Action | Stryker Orthopaedics issued an "Urgent Product Correction" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069. Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970. |
| Quantity | 27 |
| Distribution | Worldwide Distribution -- US and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.