FDA-Device2022-11-30Class II

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

Corin Ltd
Hazard

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

Sold states
Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Affected count
4 devices
Manufactured in
Unit 1-57-8, Corinium Centre, Cirencester, N/A, United Kingdom
Products
Unity Total Knee System. Used for knee prosthesis in total knee replacement

Official notice

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

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