OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedur
FDA device recall Z-1143-2012 · posted 2012-03-02 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.
- Action taken
- BIOMET Orthopedics sent an URGENT MEDICAL DEVICE recall notice dated February 7, 2012, to all affected consignees. The recall notice instructed consignees to immediate locate and remove the devices from circulation and to fax back the response form to 574-372-1683. If product was further distributed, consignees must notify hospital personnel of this action via the enclosed notice. Consignees were charged with the location and return of the affected product. For questions regarding this recall call 574-372-3983 or 574-371-3009.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 27 units distributed US and foreign
- Distribution
- Worldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands
- Date initiated
- 2012-02-07
- Date posted
- 2012-03-02
- Date terminated
- 2013-02-06
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS (K062997) | Biomet Manufacturing Corp | 2006-12-08 |