SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 137 05 16 000
Date submitted:	5/29/2016

Manufacturer:	Medtronic Inc
Device Type:	PSS Midas Rex Sagittal Saws
Description:	Motor, drill, pneumatic
Medical Device Identifier:	ES300, ES300-R, ES310, ES310-R
Reason of Field Safety Corrective Action:	Medtronic testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Remedy Action:	Medtronic will contact Health Care Professionals informing about a voluntary filed action to remove all Midas Rex Sagittal Saws from market.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	NCMDR
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic Inc..pdf

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