Z-0235-2013 Class II Terminated
FDA device recall Z-0235-2013 was initiated by Zimmer, Inc. on Sep 4, 2012 and is designated Class II. 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… The recall status is terminated (terminated Apr 16, 2014). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2012
- Initiation Date
- Sep 4, 2012
- Termination Date
- Apr 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Original M.E. Mueller" Low Profile Cup Sterile, Rx
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
Distribution Pattern
Nationwide Distribution.
Code Information
REF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0235-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026