Recall Z-3104-2017 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Stanmore Implants Worldwide Ltd.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
| Date | Jul 4, 2017 |
| Status | Terminated |
| Reason | Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended. |
| Root cause | Labeling design |
| Action | Stanmore Implants sent an Urgent Field Safety Notice dated July 4, 2017, notifying customers of the recall. Additionally, the recalling firm requests that consignees immediately check their inventory for recalled product, quarantine any product on hand, inform SIW of any product on hand, complete the attached response form, and return the response for and affected product to the firm. It is requested that consignees distribute the notice internally to all affected parties and that they contact their local Stanmore representative to request training. If any adverse events are associated with t |
| Quantity | 15 units |
| Distribution | US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX. |
| FDA record | Open on fda.gov |