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U.S. Department of Health and Human Services

Class 2 Device Recall Anatomical Shoulder" Fracture Humeral stem

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  Class 2 Device Recall Anatomical Shoulder" Fracture Humeral stem see related information
Date Initiated by Firm September 04, 2012
Date Posted November 06, 2012
Recall Status1 Terminated 3 on April 16, 2014
Recall Number Z-0224-2013
Recall Event ID 63103
510(K)Number K062029  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Anatomical Shoulder" Fracture Humeral stem
Code Information REF Numbers: 01.04207.072, 01.04207.082, 01.04207.092, 01.04207.112, 01.04207.132, 01.04207.142, 01.04217.072, and 01.04217.132. Lot 2360479, 2373842, 2331163, 2401526, 2458833, 2360473, 2451660, 2387138, 2521377, 2342166, 2455419, 2342646, 2436406, 2362563, 2413744, 2423092, 2423094, 2472576, 2433869,  
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-372-4807
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		 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 139
Distribution Nationwide Distribution.
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.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = ZIMMER GMBH
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