Class 2 Device Recall Biomet RINGLOC Instrumentation Impactor Plate

• Date Initiated by Firm: October 18, 2007
• Date Posted: February 05, 2008
• Recall Status: Terminated on March 11, 2008
• Recall Number: Z-0701-2008
• Recall Event ID: 45987
• Product Classification: Acetabular Inserter Instrument - Product Code LXH
• Product: Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.
• Code Information: Lot Number: 038680.
• Recalling Firm/ Manufacturer: 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: 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.