Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/pol
FDA device recall Z-0559-2010 · posted 2009-12-22 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
- Action taken
- Distributors, hospital consignees and an implanting surgeon were notified of the recall by an Urgent Medical Device Recall Notice, dated 11/10/09. Distributors were instructed to locate and remove the identified products from circulation. The instructions on the enclosed "FAX Back Response Form" should be followed and product from their accounts should be returned. Hospital consignees and the implanting surgeon were informed of the recall and advised of the potential health hazards presented by the mix-up.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 24 of both products.
- Distribution
- Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
- Date initiated
- 2009-11-10
- Date posted
- 2009-12-22
- Date terminated
- 2010-11-03
- 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 |
|---|---|---|
| TOGGLELOC SYSTEM (K083070) | Biomet Sports Medicine | 2008-12-16 |