Medical device recalls Moderate risk

CORIN MEDICAL, LTD. recalls Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-501…

Recall date
May 23, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2069-2025
FDA classification
Class II
Brand / firm
CORIN MEDICAL, LTD.
Sold / distributed
US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

Why it was recalled

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

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

What was recalled

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

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