Reported Sep 13, 2017 · Terminated
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or…
Stanmore Implants Worldwide Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stanmore Implants Worldwide Ltd. · Centennial Park · Borehamwood, N/A · N/A
Is this the product you have?
- JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
- Lot codes and dates
Product Code MLE3Serial No. 907-103907-104907-119907-123907-125907-126907-127907-028907-237907-240907-500907-501907-502907-503907-504
- Amount recalled
- 15 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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