Recall Z-1904-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Ortho Development Corporation
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
| Date | May 30, 2019 |
| Status | Open, Classified |
| Reason | The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified their US sales managers via teleconference on 07/19/2019. The sales managers coordinated distribution of the notification letter to the distributors and surgeons. All 12 US surgeons received both in-person verbal and written notices (hand delivered by sales reps) subsequent to the 07/19/2019 teleconference meeting. Recall actions for products sold in Japan were coordinated by the firm's parent company. In the firm's "Urgent Advisory Notice/Medical Device Recall Notice", dated 07/16/2019 includes the following instructions for end users: Contacting affected patients should |
| Quantity | 29 |
| Distribution | US: CA, FL, OH, PA, TX, and UT. OUS: Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994370 | ORTHO DEVELOPMENT BALANCED KNEE SYSTEM Ortho Development Corp., Mar 24, 2000 |