FDA-Device2018-01-10Class II
COMP PRIMARY STEM 8MM MINI, model # 113628
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
COMP PRIMARY STEM 8MM MINI, model # 113628
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0299-2018Don't want to check this manually?
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