Stanmore Implants Worldwide Ltd. recalls JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or defi…

Recall date

July 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3104-2017

FDA classification

Class II

Brand / firm

Stanmore Implants Worldwide Ltd.

Sold / distributed

US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.