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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet RINGLOC Instrumentation Impactor Plate

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  Class 2 Device Recall Biomet RINGLOC Instrumentation Impactor Plate see related information
Date Initiated by Firm October 18, 2007
Date Posted February 05, 2008
Recall Status1 Terminated 3 on March 11, 2008
Recall Number Z-0702-2008
Recall Event ID 45987
Product Classification Acetabular Inserter Instrument - Product Code LXH
Product Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.
Code Information Lot Number: 038690.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
800-348-9500 Ext. 3913
Manufacturer Reason
for Recall
The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.
FDA Determined
Cause 2
Process control
Action Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
Quantity in Commerce 141 total for all recalls Z-0700-0705-2008
Distribution Worldwide-USA, Germany, The Netherlands, Sweden and The 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.