Class 2 Device Recall InterOp Acetabular System hooded trial insert

• Date Initiated by Firm: November 15, 2010
• Date Posted: December 14, 2010
• Recall Status: Terminated on May 23, 2011
• Recall Number: Z-0619-2011
• Recall Event ID: 57304
• Product Classification: Template - Product Code HWT
• Product: Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.
• Code Information: 61438482
• Recalling Firm/ Manufacturer: Zimmer Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.
• FDA Determined Cause: Employee error
• Action: Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed. Customers can contact Zimmer at 574 371-8852 concerning this recall.
• Quantity in Commerce: 3
• Distribution: Worldwide Distribution: US in the states of KS and UT, and the country of Canada.
• 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.