Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Apex Knee System Recalled for Potential Loss of Sterile Packaging Integrity

Agency Publication Date: July 2, 2025
Share:
Sign in to monitor this recall

Summary

CORIN MEDICAL, LTD. is recalling 341 units of the Apex Knee System because the nylon packaging material has aged, leading to a loss of seal integrity in some pouches. This recall involves multiple model numbers in the KC series. Because the packaging barrier may be breached, the sterility of the surgical implants cannot be guaranteed, which could lead to medical complications.

Risk

If the packaging material loses its integrity, the sterile knee implant could become contaminated before surgery. Using a non-sterile implant increases the risk of serious post-operative infections or complications for the patient.

What You Should Do

  1. The recalled products are Apex Knee System implants with 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, and KC-55243. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device immediately to ensure no compromised implants are used in surgical procedures.
  3. Contact the manufacturer, CORIN MEDICAL, LTD., or your distributor to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions or need further guidance.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Apex Knee System
Model / REF:
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
Serial Numbers (52):
580854
582278
528456
528457
531527
532301
586311
552924
528458
548885
548886
548887
548888
573259
529093
527387
528459
555044
568751
529072
529094
565748
584973
584974
586369
528460
528461
545943
565831
565832
567009
572398
587261
587262
528462
529076
550671
585011
552532
529073
588382
529074
548468
548469
548470
584975
589609
586115
586117
584976

Recall initiated due to age of nylon packaging material causing loss of pouch integrity.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97006
Status: Active
Manufacturer: CORIN MEDICAL, LTD.
Sold By: Hospitals; Surgical Centers; Medical Distributors
Manufactured In: United Kingdom
Units Affected: 341 units
Distributed To: California, Colorado, Florida, Illinois, Oklahoma, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.