Recall Z-0448-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
| Date | Dec 11, 2007 (initiated Sep 19, 2006) |
| Status | Terminated |
| Reason | Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly. |
| Root cause | Device Design |
| Action | Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product |
| Quantity | 2,868 units total for Recalls Z-0448-0450-2008 |
| Distribution | Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.