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