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Recall Observatory FDA recall evidence

Device product

NCB¿ cancellous screw

Z-0243-2013

September 04, 2012

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 63103
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0243-2013

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 Number: 02.02152. 085 Lot 2477869

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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