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

Apex Knee System components recalled over loss of sterile packaging integrity

Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.

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: Risk-of-harm product: a compromised sterile barrier on an implantable orthopaedic component, with no injury reported in the source.

Plain-English summary

The Apex Knee System is being recalled across the model numbers listed in the recall notice, including KC-50090, KC-50110, KC-50130, KC-50157, KC-52104 and KC-55223. The action covers 341 units, identified by the serial numbers paired with each model number in the notice.

The stated reason is that an investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. The FDA classified the action as Class II.

Distribution was nationwide in the United States, in California, Colorado, Florida, Illinois, Oklahoma, Texas and Utah. The components are supplied to surgical facilities rather than sold to consumers.

Facilities should identify affected stock using the model and serial numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.

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 — Orthopaedic implant
Hazard
Affected units
341

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.

The notice also names 7 states specifically:

Related recalls

Same hazard · sterile barrier

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