—#86791

Product

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 product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083070
Affected lot / code info: Lot 101780.

Why it was recalled

Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.

Timeline

Recall initiated: 2009-11-10
Posted by FDA: 2009-12-22
Terminated: 2010-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86791. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.