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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet bone mulch screw

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  Class 2 Device Recall Biomet bone mulch screw see related information
Date Initiated by Firm December 22, 2009
Date Posted February 02, 2010
Recall Status1 Terminated 3 on October 22, 2010
Recall Number Z-0779-2010
Recall Event ID 54141
510(K)Number K941941  
Product Classification Bone Mulch Screw - Product Code HWC
Product Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.
Code Information Lots 918790, 918800 and 110700.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
800-348-9599 Ext. 3983
Manufacturer Reason
for Recall		 The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.
FDA Determined
Cause 2		 Employee error
Action Hospitals, distributors, and other customers were notified by letter dated 12/22/09 and instructed to locate and return these lots of product. Questions related to this notice should be directed to the firm at 800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.
Quantity in Commerce 169
Distribution Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway.
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 = HWC and Original Applicant = BIOMET, INC.
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