Z-2069-2025Class II

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137...

Name: Z-2069-2025 Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137...
Creator: Corin Medical, Ltd.
Published: 2025-05-23
License: https://open.fda.gov/license/

Corin Limited / initiated 2025-05-23 / Open, Classified / root cause: manufacturing process

FDA source

CORIN MEDICAL, LTD. began a recall of 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... on 2025-05-23. FDA classified it as Class II and gives the reason as "Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2069-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2025-07-02
Recalling firm: Corin Limited
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
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Corin Group notified US agents informally via email on 05/23/2025 and informed them of an investigation and affected inventory to quarantine. A formal notification was sent to consignees on about 06/02/2025. Consignees were instructed to identify any affected units on hand and quarantine them, return them to Corin and notify all affected parties who handled the product. Consignees were also requested to complete and return the acknowledgement form. If product was further distributed, Corin requested contact information to contact those customers.
Quantity in commerce: 341 units
Distribution: US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.
Product codes and lots: Model Number (Serial Numbers): KC-50090(580854, 582278), KC-50097(528456, 528457), KC-50110(531527, 532301, 586311), KC-50117(552924), KC-50130(528458, 548885, 548886, 548887, 548888, 573259), KC-50135(529093), KC-50137(527387, 528459, 555044, 568751), KC-50150(529072, 529094, 565748, 584973, 584974), KC-50155(586369), KC-50157(528460, 528461, 545943, 565831, 565832, 567009, 572398, 587261, 587262), KC-50170(528462, 529076, 550671, 585011), KC-50175(552532), KC-50177(529073, 588382), KC-50190(529074), KC-50197(548468, 548469, 548470), KC-52104(584975), KC-52554(589609), KC-52574(586115, 586117), KC-52774(584976), KC-55223(580117), KC-55243(580855).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2069-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2069-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-02

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)