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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy

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 Class 2 Recall
Trilogy
see related information
Date Posted November 20, 2012
Recall Status1 Terminated on August 27, 2013
Recall Number Z-0386-2013
Recall Event ID 63126
Premarket Notification
510(K) Number
K071718 
Product Classification Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer - Product Code KWZ
Product Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Code Information Item 00-6334-062-36, Lot 62023769
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Dona Reust
574-372-4807
Manufacturer Reason
for Recall
Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall. The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed. For further questions please call 574-372-4316.
Quantity in Commerce 1
Distribution USA (nationwide) including the states of Ohio, Carolinas and New England.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWZ and Original Applicant = ZIMMER, INC.
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