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Terminated

Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.

FDA Recall Z-2042-2009 · Posted 2009-09-08

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWE
Date Initiated2009-08-06
Date Terminated2010-10-06
Product Quantity2

Reason for Recall

These surgical instruments are etched with incorrect measurement markings.

Firm Action

Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution -- Including the state of Texas.

Official Source

View FDA Recall →

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

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