Recall Z-1623-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stanmore Implants Worldwide Ltd.
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
| Date | May 9, 2016 (initiated Apr 12, 2016) |
| Status | Terminated |
| Reason | Incorrect component used to manufacture distal femoral replacement. |
| Root cause | Mixed-up of materials/components |
| Action | A notification was sent to the prescribing physician on 04/12/2016. |
| Quantity | 1 |
| Distribution | US distribution to OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.