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U.S. Department of Health and Human Services

Class 2 Device Recall InterOp Acetabular System hooded trial insert

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  Class 2 Device Recall InterOp Acetabular System hooded trial insert see related information
Date Initiated by Firm November 15, 2010
Date Posted December 14, 2010
Recall Status1 Terminated 3 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 2		 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.
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