Recall Z-0223-2013 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Zimmer, Inc.
Anatomical Shoulder" Humeral stem
| Date | Nov 6, 2012 (initiated Sep 4, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 260 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030259 | AMATOMICAL SHOULDER WITH REMOVABLE HEAD Centerplus Orthopedics, Inc., Apr 24, 2003 |