Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.
FDA device recall Z-2042-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- These surgical instruments are etched with incorrect measurement markings.
- Action taken
- 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
- Status
- Terminated
- Product code
- HWE
- Quantity affected
- 2
- Distribution
- Nationwide Distribution -- Including the state of Texas.
- Date initiated
- 2009-08-06
- Date posted
- 2009-09-08
- Date terminated
- 2010-10-06
- Location
- Warsaw, IN
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