FDA recall Z-0084-2021

Product

Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055

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-0084-2021