FDA-Device2018-01-10Class II
OSS CEMENTED IM STEM 12X150, model # 150366
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
OSS CEMENTED IM STEM 12X150, model # 150366
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0303-2018Don't want to check this manually?
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