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U.S. Department of Health and Human Services

Class 2 Device Recall Alloclassic

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 Class 2 Recall
Alloclassic
see related information
Date Posted November 06, 2012
Recall Status1 Terminated on April 16, 2014
Recall Number Z-0214-2013
Recall Event ID 63103
Premarket Notification
510(K) Number
K033664 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
Product Alloclassic® SL-Offset Stem sterile, Rx
Code Information REF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090.
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Manufacturer Reason
for Recall
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
Quantity in Commerce 126
Distribution Nationwide Distribution.
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 = LZO and Original Applicant = CENTERPULSE ORTHOPEDICS, INC.
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