Class 2 Device Recall Modular Microplasty Cup impactor 1/4" 28 thread insert

• Date Initiated by Firm: July 28, 2010
• Date Posted: September 25, 2010
• Recall Status: Terminated on October 01, 2012
• Recall Number: Z-2505-2010
• Recall Event ID: 56591
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
• Code Information: 106623, 106624, 106625, 106626, 106627, 106628 110405 and 110423.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Mary Johnson; 574-267-6639 Ext. 1676
• Manufacturer Reason for Recall: There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" The recalling frim conducted tests to determine the effects of theis change in materials. The testing showed that the wire would oxidize and there would be early failure of the device.
• FDA Determined Cause: Employee error
• Action: The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet.
• Quantity in Commerce: 331 total for both products
• Distribution: US, Australia, Canada, Mexico, Chile, Japan.
• 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.