Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581
FDA device recall Z-0706-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
- Action taken
- Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 8
- Distribution
- Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.
- Date initiated
- 2007-12-12
- Date posted
- 2008-01-31
- Date terminated
- 2008-06-11
- 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 |