FDA-Device2025-07-09Class II
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
CORIN MEDICAL, LTD.
Hazard
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Sold states
US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.
Affected count
341 units
Manufactured in
Unit 1-57-8, Corinium Centre, Cirencester, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2025Don't want to check this manually?
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