FDA Medical Device Recalls (openFDA)
CORIN MEDICAL, LTD.: 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
- Recall number
- Z-2069-2025
- Recalling firm
- CORIN MEDICAL, LTD.
- 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
- Status
- Open, Classified
- Initiated
- 2025-05-23
- Posted
- 2025-07-02
- Terminated
- not on file
- Reason
- Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
- 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
- 341 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K101994","K153437","K112891"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3002806725
- Firm city
- Cirencester
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28