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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Trilogy Acetabular Shell

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 Class 2 Recall
Zimmer Trilogy Acetabular Shell
see related information
Date Posted March 19, 2008
Recall Status1 Terminated on May 21, 2008
Recall Number Z-0620-2008
Recall Event ID 45479
Premarket Notification
510(K) Number
K934765 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.
Code Information Lot Number: 26208600; exp. 2013-02.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.
Quantity in Commerce 31
Distribution Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.
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 = LPH and Original Applicant = ZIMMER, INC.
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