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Terminated

Biomet Ascent SI knee instruments sliding femoral 4-in-1 block, x-small, stainless steel; Ref. RD140629.

FDA Recall Z-1449-05 · Posted 2005-08-31

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHTZ
Date Initiated2005-05-16
Date Terminated2005-09-08
Product Quantity163

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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