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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 Recall
Biomet bone mulch screw
see related information
Date Posted February 02, 2010
Recall Status1 Terminated on October 22, 2010
Recall Number Z-0779-2010
Recall Event ID 54141
Premarket Notification
510(K) Number
K941941 
Product Classification Screw, Fixation, Bone - 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, Indiana 46582
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
TRAINING: 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 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, INC.
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