Recall Z-0356-2027 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
CORIN MEDICAL, LTD.
Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
| Date | Nov 3, 2026 (initiated Oct 2, 2026) |
| Status | Open, Classified |
| Reason | Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will not be able to be disengaged, and the handle will be unable to fitted securely to any unengaged mating instruments. |
| Root cause | Under Investigation by firm |
| Action | Corin notified consignees on about 10/02/2026 via emailed "URGENT MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to identify the products present in inventory and quarantine them, return the devices to Corin (replacement parts will be provided), provide the notification letter to all involved parties, and complete and return the acknowledgement form. Additionally, Corin requested notification if affected units have been further distributed as well as any affected customers so that they may be notified. |
| Quantity | 22 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, GA, IL, MI, NC, RI, TX, UT and the countries of Belgium, France, Germany, Hungary. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113060 | UNITY TOATAL KNEE SYSTEM Corin USA, Sep 10, 2012 |