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U.S. Department of Health and Human Services

Class 2 Device Recall Toggleloc System

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  Class 2 Device Recall Toggleloc System see related information
Date Initiated by Firm November 10, 2009
Date Posted December 22, 2009
Recall Status1 Terminated 3 on November 03, 2010
Recall Number Z-0560-2010
Recall Event ID 53878
510(K)Number K083070  
Product Classification Soft Tissue Nondegradable Fixation Fastener - Product Code MBI
Product Toggleloc System, Biomet Ziptight Ankle Syndesmosis Fixation System - SS with Ziploop Technology, polyethylene/polypropylene/ polyester/ stainless steel, sterile Biomet Sports Medicine, Warsaw, IN.; REF 909857.

A smooth or threaded metallic bone fixation fastener intended to be implanted for fixation of bone fractures.
Code Information Lot 101840.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
800-348-9500
Manufacturer Reason
for Recall		 Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
FDA Determined
Cause 2		 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 in Commerce 24 of both products.
Distribution Nationwide Distribution -- Including states of California, Florida, South Carolina, and Virginia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = BIOMET SPORTS MEDICINE
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