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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Product Detail

Product Description Anatomical Shoulder" Inverse Humeral Cup
Recall Number Z-0229-2013
Classification Class II
Code Info REF Numbers: 01.04223.100, 01.04223.106, 01.04223.111, 01.04223.121, 01.04223.190, and 01.04223.196.Lot 2310656, 2429295, 2468509, 2310648, 2410046, 2486362, 2474203, 2317777
Product Distributed Qty 66
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 information on the patient label (in rare cases) may be wrong.

Event Detail

Event Id 63103
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.