FDA-Device2017-09-13Class II
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Stanmore Implants Worldwide Ltd.
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.
Sold states
US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
Affected count
15 units
Manufactured in
Centennial Park, 210 Centennial Avenue; CENTENNIAL PARK, Borehamwood, N/A, United Kingdom
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3104-2017Don't want to check this manually?
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