Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 137 05 16 000
PSS Midas Rex Sagittal Saws
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.
Medtronic will contact Health Care Professionals informing about a voluntary filed action to remove all Midas Rex Sagittal Saws from market.
Gulf Medical Co.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.