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U.S. Department of Health and Human Services

Class 2 Device Recall Toggleloc Artificial ligament fixation device

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  Class 2 Device Recall Toggleloc Artificial ligament fixation device see related information
Date Initiated by Firm March 31, 2010
Date Posted July 01, 2010
Recall Status1 Terminated 3 on August 06, 2012
Recall Number Z-1953-2010
Recall Event ID 55776
510(K)Number K083070  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN.

Intended for soft tissue to bone fixation.
Code Information Lot Numbers: 228150, 228160, 783930, 975220, 975230 and 975240.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.
FDA Determined
Cause 2		 Process control
Action Biomet Sports Medicine issued an "Urgent Medical Device Recall Notice" dated March 31, 2010 to user facilities and distributors. A second notification containing updated information was issued June 2, 2010. Consignees were instructed to discontinue use of the product and return it to the firm along with a completed Response Form. For further information, contact Biomet at 1-574-371-3755 or 1-574-371-3756, Monday through Friday, 8AM to 5PM.
Quantity in Commerce 2466 both products
Distribution Worldwide Distribution -- United States, Canada, Australia, The Netherlands, Belgium, Italy, France, New Zealand, Austria, United Kingdom, Chile, Greece, Poland, Denmark, Turkey, Portugal, South Africa and Spain.
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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