Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | Original M.E. Mueller" Low Profile Cup Sterile, Rx |
|---|---|
| Recall Number | Z-0235-2013 |
| Classification | Class II |
| Code Info | REF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934 |
| Product Distributed Qty | 6 |
| 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. |
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