Recall Z-0559-2010 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Biomet, Inc.
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.
| Date | Dec 22, 2009 (initiated Nov 10, 2009) |
| Status | Terminated |
| Reason | Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 24 of both products. |
| Distribution | Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083070 | TOGGLELOC SYSTEM Biomet Sports Medicine, Dec 16, 2008 |