REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE STERILE, R, Biomet Orthopedics
FDA device recall Z-1438-2012 · posted 2012-04-19 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and measured against print specifications.
- Action taken
- Biomet sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to continue monitoring implanted patients for disassociation of the pin component and report to Biomet. The Alert included a complete listing of device invoice history and patient information (if supplied). Contact the firm for confirmation of receipt of the notice and for questions at 574-372-3983.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 64 units distributed
- Distribution
- Distributed in California and Pennsylvania.
- Date initiated
- 2012-03-20
- Date posted
- 2012-04-19
- Date terminated
- 2013-02-07
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAK OSS KNEE FEMORAL COMPONENTS (K083779) | Biomet Manufacturing Corp | 2009-04-03 |