Recall Z-2069-2025— CORIN MEDICAL, LTD.

Name: FDA recall Z-2069-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-23

Class II · Ongoing

Class II FDA medical device recall by CORIN MEDICAL, LTD., initiated 2025-05-23. It names 3 FDA 510(k) clearances: K153437, K112891, K101994. Product: 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: Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches..

Recalling firm: CORIN MEDICAL, LTD.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-23
Firm location: Cirencester, United Kingdom

510(k) clearances named in this recall

3 on FDA's record

K153437 — Apex Revision Knee SystemOmnilife Science·cleared 2015-12-21
K112891 — APEX REVISION KNEE SYSTEMSOmni Life Science, Inc.·cleared 2012-02-29
K101994 — APEX KNEE MODULAR TIBIA SYSTEMOmnlife Science·cleared 2010-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.