FDAJuly 4, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

stanmore implants worldwidestanmorestanmore implants

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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