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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 devicesee related information
Date Initiated by FirmMarch 31, 2010
Date PostedJuly 01, 2010
Recall Status1 Terminated 3 on August 06, 2012
Recall NumberZ-1953-2010
Recall Event ID 55776
510(K)NumberK083070 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductToggleloc 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
ActionBiomet 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 Commerce2466 both products
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MBI
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