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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 187 11 13 000
Date submitted: 11/28/2013
Manufacturer:Aesculap
Device Type:TARGON FN TELESCREWS
Description:The Targon® FN TeleScrews allow a controlled collapse of the fracture along the line of the femoral neck without any backing out of the screws into the soft tissues.
Medical Device Identifier:TARGON FN TELESCREWS KO820T, KO822T, KO823T, KO824T, KO825T, KO826T, KO828T
Reason of Field Safety Corrective Action:Internal tests at Aesculap have shown that Targon FN screws can occasionally be difficult to screw into the Targon FN femoral plates.
Remedy Action:Due to the design, the required tightening torque of 8 Nm can be achieved after just half a turn of the screw, depending on the tolerance of the TeleScrew and plate. To ensure a secure connection between the Targon FN plate and the TeleScrews, it is generally recommended to check that the threads of both the Targon FN plate and the TeleScrew are free from any bone particles, blood or tissue before screwing them in. In case of doubt and if you encounter any problems screwing the TeleScrew into the plate, take the TeleScrew out again and clean the thread of the plate and the TeleScrew. Your Aesculap Consultant for Medical Devices will provide you with the updated version of the operating manuals as soon as it is available.
Athorized Representative/Importer/Distributor:Gulf Medical Co., (012)6512828
Report Source:NCMDR
Source Ref. Number:EED36141CD330
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: TARGON FN TELESCREWS.pdf