FDA recall Z-0083-2021

Biomet, Inc. · Class II · device

Product

Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055

Reason for recall

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

Distribution

Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

Key facts

Status: Terminated
Initiation date: 2020-09-04
Report date: 2020-10-14
Termination date: 2021-08-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0083-2021