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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Orthopedics Apical Hole Plug

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  Class 2 Device Recall Biomet Orthopedics Apical Hole Plug see related information
Date Initiated by Firm August 09, 2007
Date Posted October 27, 2007
Recall Status1 Terminated 3 on June 26, 2009
Recall Number Z-0102-2008
Recall Event ID 44812
510(K)Number K0703692  
Product Classification Apical Hole Plug - Product Code LPH
Product Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581
Code Information Lot 522080.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact Paula Richardson
800-348-9500
Manufacturer Reason
for Recall		 Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.
FDA Determined
Cause 2		 Process control
Action The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts
Quantity in Commerce 5
Distribution Nationwide
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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