FDA-Device2020-10-14Class II
Biomet Regenerex Primary Taper Cap Item Number 141269
Biomet, Inc.
Hazard
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Sold states
Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
Affected count
US: 62 units; OUS: 176 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Biomet Regenerex Primary Taper Cap Item Number 141269
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0081-2021Don't want to check this manually?
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