Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - Titanium with Ziploop Technology, polyethylene/polypropylene/ polyester/TI-6AL-4V alloy/S.S., sterile Biomet Sports Medicine, Warsaw, IN.; REF 909853. A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.
This recall has been terminated (originally issued December 22, 2009).
- Company
- Biomet, Inc.
- Recall Initiated
- November 10, 2009
- Posted
- December 22, 2009
- Terminated
- November 3, 2010
- Recall Number
- Z-0559-2010
- Quantity
- 24 of both products.
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
Distribution
Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
Lot / Code Info
Lot 101780.
Root Cause
Labeling mix-ups
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.