PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 9, 2025 Initiated: May 23, 2025 #Z-2069-2025

Product Description

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

Reason for Recall

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

Details

Recalling Firm
CORIN MEDICAL, LTD.
Units Affected
341 units
Distribution
US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.
Location
Cirencester

Frequently Asked Questions

What product 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. Recalled by CORIN MEDICAL, LTD.. Units affected: 341 units.
Why was this product recalled?
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 9, 2025. Severity: Moderate. Recall number: Z-2069-2025.