Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 1831
FDA device recall Z-0123-2008 · posted 2007-12-05 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.
- Action taken
- Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 16
- Distribution
- Nationwide.
- Date initiated
- 2007-08-31
- Date posted
- 2007-12-05
- Date terminated
- 2008-06-04
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXIM ACCEL KNEE SYSTEM (K023546) | Biomet, Inc. | 2003-01-17 |