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U.S. Department of Health and Human Services

Class 3 Device Recall lactoscrew

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  Class 3 Device Recall lactoscrew see related information
Date Initiated by Firm November 10, 2005
Date Posted December 28, 2005
Recall Status1 Terminated 3 on January 12, 2006
Recall Number Z-0329-06
Recall Event ID 34021
Product Classification Bit, Surgical - Product Code GFG
Product Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
Code Information Lots 044250, 134170, 781690, 781700, 838920, 914620 and 914630.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
800-348-9500 Ext. 1310
Manufacturer Reason
for Recall		 The bit may bend or fracture during use.
FDA Determined
Cause 2		 Other
Action Consignees were notified to return the product via letter dated 11/10/05.
Quantity in Commerce 46
Distribution Nationwide, Australia, Belgium, Columbia, Finland, Israel, Poland and United Kingdom.
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.
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