The Recall Desk
HighFDA (Devices)·Z-2069-2025·Announced 2025-07-09

Apex Knee System Recalled for Aged Packaging Material Integrity Loss

CORIN MEDICAL is recalling 341 units of the Apex Knee System due to aged nylon packaging material that may lose integrity. The systems were distributed nationwide in California, Colorado, Florida, Illinois, Oklahoma, Texas, and Utah.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of a medical device where packaging integrity loss poses a risk to device sterility and safety. No illnesses or injuries have been reported.

Plain-English summary

CORIN MEDICAL is recalling 341 units of the Apex Knee System due to aging of the nylon packaging material. Affected model numbers include 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, and KC-55243.

Investigation identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. The affected units were distributed nationwide to California, Colorado, Florida, Illinois, Oklahoma, Texas, and Utah.

Patients who received these devices should contact their healthcare provider to discuss whether the recall affects their implant and for guidance on next steps.

The recalled product

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
Manufacturer
CORIN MEDICAL, LTD.
Category
Medical Device — Orthopedic Implant
Hazard
  • packaging-integrity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category