Recall Z-1450-05 ยท HTZ Instrument, Cutting, Orthopedic
Biomet, Inc.
Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, small, stainless steel; Ref. RD140630.
| Date | Aug 31, 2005 (initiated May 16, 2005) |
| Status | Terminated |
| Reason | The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery. |
| Root cause | Other |
| Action | Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component. |
| Quantity | 177 |
| Distribution | Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.