FDA-Device2020-10-14Class II
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
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: 33 units; OUS: 269 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2021Don't want to check this manually?
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