Stanmore Implants Worldwide Ltd.: Medical Device Recall in 2017 - (Recall #: Z-3104-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 4, 2017

Date Posted: September 13, 2017

Recall Number: Z-3104-2017

Event ID: 77753

Reason for Recall:

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.

Status: Terminated

Product Quantity: 15 units

Code Information:

Product Code MLE3; Serial No. 907-103, 907-104, 907-119, 907-123, 907-125, 907-126, 907-127, 907-028, 907-237, 907-240, 907-500, 907-501, 907-502, 907-503, 907-504.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated