FDA Device recall Z-2069-2025

Apex Knee System

FDA Device
Class II
ongoing
Published 2025-07-09

On 2025-07-09 the FDA classified a Class II recall of Apex Knee System by Corin Medical, citing investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2069-2025
Classification	Class II
Status	ongoing
Initiated	2025-05-23
Published	2025-07-09
Last updated	2026-09-13 11:57 UTC
Company	Corin Medical
Distribution	US

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.

Identifiers

code_info	Model Number (Serial Numbers): KC-50090(580854, 582278), KC-50097(528456, 528457), KC-50110(531527, 532301, 586311), KC… 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).

code_info

Model Number (Serial Numbers): KC-50090(580854, 582278), KC-50097(528456, 528457), KC-50110(531527, 532301, 586311), KC…

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).

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2069-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.