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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 026 06 15 001
Date submitted: 10/11/2015
Manufacturer:Medtronic Inc
Device Type:Medtronic Navigation Cannulated Taps
Description:Cannulated Taps, reusable devices
Medical Device Identifier:Affected Model numbers are listed in the attached letter
Reason of Field Safety Corrective Action:Cannulated taps have the potential to accumulate bone and other tissue in the cannula.
Remedy Action:The manufacturer is modifying the instructions for use for the cannulated taps to clearly detail the potential for bone/tissue accumulation in the cannula of the devices if they are used without a guide wire and to caution the user during the cleaning process. If the obstruction in the cannula cannot be removed, the instructions for use indicate that the devices should be considered at the end of their useful life and should be discarded in accordance with your facility procedures and guidelines. A copy of the updated instructions for use will be sent to you within the next 2 months.


NCMDR update action :

As a follow up to the May 2015 communication, Medtronic is now distributing the updated Instructions For Use for the model numbers listed in appendix 1 to all users of these devices.
Please ensure that the updated Instructions For Use are provided to the personnel within your facility that perform spinal surgeries and also those individuals responsible for cleaning and sterilization of these devices.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:D21018F7EF2E0
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc.pdf