Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232,
FDA device recall Z-0255-2008 · posted 2007-11-24 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Mislabeled as to size: the package actaully contained a 71 mm tray.
- Action taken
- Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 7
- Distribution
- Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.
- Date initiated
- 2007-09-18
- Date posted
- 2007-11-24
- Date terminated
- 2008-06-04
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM (K915132) | Biomet, Inc. | 1992-02-11 |