Recall Z-2069-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
| Date | Jul 2, 2025 (initiated May 23, 2025) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |