CORIN MEDICAL, LTD.: Device Recall

Recall #Z-2069-2025 · 05/23/2025

Class II: Risk

Recall Details

Recall Number
Z-2069-2025
Classification
Class II
Product Type
Device
Recalling Firm
CORIN MEDICAL, LTD.
Status
Ongoing
Date Initiated
05/23/2025
Location
Cirencester, United Kingdom
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
341 units

Reason for Recall

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

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

Distribution Pattern

US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.