Class 2 Device Recall Biomet Exact Calcar Planer Rasp Style Blade

• Date Initiated by Firm: July 18, 2008
• Date Posted: September 29, 2008
• Recall Status: Terminated on June 26, 2009
• Recall Number: Z-2372-2008
• Recall Event ID: 49013
• Product Classification: Blade - Product Code GFA
• Product: Exact Calcar Planer Rasp Style Blade, 46mm, Biomet Orthopedics, Inc, Warsaw, IN; REF 31-473797. Surgical blades used to remove excess bone proximal to the broach face to all instrument trial to seat properly.
• Code Information: Lots 850560, 439390, 848560 and 918030.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46581-0587
• For Additional Information Contact: 800-348-9500 Ext. 3983
• Manufacturer Reason for Recall: The blades will oxidize after the first cleaning.
• FDA Determined Cause: Process control
• Action: Distributors were notified via letter dated 7/18/08 to locate and remove the products and to return them. Distributors were instructed to conduct the recall to the hospital level and to notify the hospitals of the recall by copy of an undated recall letter. Contact Biomet, Inc. at 1-800-348-9500, ext. 3983 for assistance.
• Quantity in Commerce: 141 of all products
• Distribution: Nationwide and China.
• 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.