Corin Ltd recalls Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of…

Recall date

July 28, 2021

Source

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

Recall number

Z-2610-2021

FDA classification

Class II

Brand / firm

Corin Ltd

Sold / distributed

US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

Why it was recalled

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

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

What was recalled

Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.