Corin Ltd recalls Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

Recall date

October 13, 2023

Source

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

Recall number

Z-0214-2024

FDA classification

Class II

Brand / firm

Corin Ltd

Sold / distributed

US: MI, TX, IL

Why it was recalled

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.

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, Model Number 112.001.34. Primary and revision total knee arthroplasty