Class 2 Device Recall Biomet Microplasty Cup Impactor

• Date Initiated by Firm: January 16, 2008
• Date Posted: August 20, 2008
• Recall Status: Terminated on September 22, 2009
• Recall Number: Z-1186-2008
• Recall Event ID: 46345
• Product Classification: Instrument for hip prosthesis acetabular cup component. - Product Code LXH
• Product: Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
• Code Information: Lot 095207.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46581-0587
• For Additional Information Contact: Mary Hardesty; 800-348-9500
• Manufacturer Reason for Recall: The weld at the lock location may fracture during impaction.
• FDA Determined Cause: Device Design
• Action: Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.
• Quantity in Commerce: 59
• Distribution: Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and 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.