FDA recall Z-0081-2021

Product

Biomet Regenerex Primary Taper Cap Item Number 141269

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-0081-2021