FDA recall Z-0213-2024

Product

Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty

Reason for recall

Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Distribution

US: MI, TX, IL

Key facts

Status

Ongoing

Initiation date

2023-10-13

Report date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cirencester, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0213-2024