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U.S. Department of Health and Human Services

Class 2 Device Recall Lactoscrew Anchors

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 Class 2 Recall
Lactoscrew Anchors
see related information
Date Posted March 21, 2012
Recall Status1 Terminated on April 12, 2013
Recall Number Z-1235-2012
Recall Event ID 61104
Premarket Notification
510(K) Number
K080088 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.
Code Information 622920
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Manufacturer Reason
for Recall
Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications, Contraindications, Possible Adverse Effects, and some Warnings are not present with the packaged device.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Biomed Inc. sent an Urgent Medical Device Recall Notice dated January 25, 2012 to distributors, hospitals, and OR managers via US mail. The notice identified the product, description of problem, possible adverse health consequences, and actions to be taken, including directions to immediately locate devices and stop device use ,with directions for return. A copy of the correct package insert was included with directions to report any procedures performed outside of indications for use. Receipt confirmation was requested by calling 800-348-9500, extension 3983 or 3009. The notice included a list of units invoiced to the account with a FaxBack Response form to be filled out and sent to the Attention of Angie Dickson, Biomet, 56 East Bell Drive Warsaw, In 46580. Questions concerning the recall should be directed to 574-371-3983 or 574-371-3009, M-F 8-5PM(EST).
Quantity in Commerce 11
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = BIOMET MANUFACTURING, INC.
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