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U.S. Department of Health and Human Services

Class 2 Device Recall Compress Short Anchor Plug Holder 13mm

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  Class 2 Device Recall Compress Short Anchor Plug Holder 13mm see related information
Date Initiated by Firm July 18, 2008
Date Posted January 07, 2009
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0521-2009
Recall Event ID 49014
510(K)Number K043547)  
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038.

Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
Code Information Lot 991680.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
800-348-9500 Ext. 3983
Manufacturer Reason
for Recall		 The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
FDA Determined
Cause 2		 Process control
Action Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983.
Quantity in Commerce 41 of all products.
Distribution Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.
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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