Recall Z-2042-2009 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Biomet, Inc.
Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.
| Date | Sep 8, 2009 (initiated Aug 6, 2009) |
| Status | Terminated |
| Reason | These surgical instruments are etched with incorrect measurement markings. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 2 |
| Distribution | Nationwide Distribution -- Including the state of Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.