Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint re
FDA device recall Z-2945-2011 · posted 2011-08-04 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.
- Action taken
- Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 8
- Distribution
- Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.
- Date initiated
- 2011-07-06
- Date posted
- 2011-08-04
- Date terminated
- 2012-09-26
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXIM ACCEL KNEE SYSTEM (K023546) | Biomet, Inc. | 2003-01-17 |