Biomet Vanguard microplasty slidex femoral 4-in-1 block, 80 mm, stainless steel; Ref. 32-485108.
FDA device recall Z-1448-05 · posted 2005-08-31 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTZ
- Quantity affected
- 63
- Distribution
- Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.
- Date initiated
- 2005-05-16
- Date posted
- 2005-08-31
- Date terminated
- 2005-09-08
- Location
- Warsaw, IN
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