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U.S. Department of Health and Human Services

Class 2 Device Recall Apex Knee System

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 Class 2 Device Recall Apex Knee Systemsee related information
Date Initiated by FirmMay 23, 2025
Date PostedJuly 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2069-2025
Recall Event ID 97006
510(K)NumberK101994 K112891 K153437 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductApex 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
Code Information 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).
FEI Number 3002806725
Recalling Firm/
Manufacturer		 CORIN MEDICAL, LTD.
Unit 1-57-8
Corinium Centre
Cirencester United Kingdom
For Additional Information ContactJon Taylor
441285659866
Manufacturer Reason
for Recall		Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCorin 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 in Commerce341 units
DistributionUS Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
510(K)s with Product Code = JWH
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