FDAFDA · Food and drugs·Recall number Z-3104-2017
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Published September 13, 2017 · Recall initiated: July 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Distributor
- US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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