FDA-Device2018-01-10Class II

RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817

Zimmer Biomet, Inc.
Hazard

Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Sold states
Nationwide in US; Internationally Argentina, Netherlands & Canada
Affected count
N/A
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0304-2018

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