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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
zimmer Anatomical Shoulder		see related information
Date Posted November 06, 2012
Recall Number Z-0227-2013
Product Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
Code Information REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901, 2435527, 2398475
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
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 Winterthur, 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
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 45 USA
Distribution Nationwide Distribution.
 
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