Device product
Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile
Z-0238-2013
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 63103
- Status
- Terminated
- Classification
- Class II
- Quantity
- 973
- Official record key
device-enforcement:Z-0238-2013
Official wording
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
Code information: REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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