Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vang
FDA device recall Z-0698-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.
- Action taken
- Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- JWH
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.
- Date initiated
- 2011-10-04
- Date posted
- 2012-01-11
- Date terminated
- 2013-04-08
- 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 |
|---|---|---|
| VANGUARD PATELLA COMPONENTS (K040770) | Biomet Manufacturing, Inc. | 2004-04-22 |