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

Recall date

October 31, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0273-2023

FDA classification

Class II

Brand / firm

Corin Ltd

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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