FDA recall Z-0273-2023

Product

Unity Total Knee System. Used for knee prosthesis in total knee replacement

Reason for recall

The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Distribution

Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.

Key facts

Status

Terminated

Initiation date

2022-10-31

Report date

2022-11-30

Termination date

2024-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cirencester, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0273-2023