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.
FDA Recall Z-0559-2010 · Posted 2009-12-22
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeMBI
Date Initiated2009-11-10
Date Terminated2010-11-03
Product Quantity24 of both products.
Reason for Recall
Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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