FDA-Device2018-01-10Class II
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
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 12MM HUM FRAC STEM MACRO, model # 11-113562
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0298-2018Don't want to check this manually?
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