Recall Z-1935-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
CORENTEC CO., LTD
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
| Date | May 31, 2024 (initiated Mar 29, 2024) |
| Status | Open, Classified |
| Reason | Due to unsupported 10 year expiration date. |
| Root cause | Labeling Change Control |
| Action | On 03/29/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that on 7/1/2020 the firm changed the labeling of their polyethylene (PE) and patella inserts from a 5 year shelf life to a 10 year shelf life. This change was made without adequate documentation evidence to support the increase in shelf life. Customers are instructed to: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at |
| Quantity | 35 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX. |
| FDA record | Open on fda.gov |