Apex Knee System — Class II medical device recall Z-2069-2025

Ongoing recall by CORIN MEDICAL, LTD., reported 2025-07-09, distributed nationwide. Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of so

Recall number	`Z-2069-2025`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	CORIN MEDICAL, LTD., Cirencester, United Kingdom
Recall initiated	2025-05-23
Classified	2025-07-02
Reported by FDA	2025-07-09
Distributed	Nationwide (US)
Quantity	341 units
Serial numbers	`528459`, `528461`, `529076`, `529094`, `532301`, `545943`, `548469`, `548885`, `548886`, `548887`, `548888`, `550671`, `555044`, `565748`, `565831`, `565832`, `567009`, `572398`, `584973`, `587261`
Model numbers	`528459`, `528461`, `529076`, `529094`, `532301`, `545943`, `548469`, `548885`, `548886`, `548887`, `548888`, `550671`, `555044`, `565748`, `565831`, `565832`, `567009`, `572398`, `584973`, `587261`, `KC-50090`, `KC-50097`, `KC-50110`, `KC-50117`, `KC-50130` and 16 more

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2069-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.