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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 142 09 12 000
Date submitted: 9/17/2012
Manufacturer:Synthes Inc
Device Type:Drills, Bone, Vectra System Graduated 2.5 mm Drill Bits and adjustable drill stop.
Description:Bur/Drill Bit Guards, Drills, Bone
Medical Device Identifier: (1) Drill Bit 0 2.5mm, compl., 2-flute 03.613.010 (2) 2.5mm drill bit, graduated 12mm- 26mm adjustable depth. 03.613.011 (3) Adjustable Drill Stop 03.613.012
Reason of Field Safety Corrective Action:There is the potential for the drill stop to slip on the drill bit
Remedy Action: Please immediately cease use of the 2.5mm adjustable drill bit (03.614.011) and the adjustable drill stop (03.613.012) as well as the drill bit complete (03.613.010). Please do not utilize self-tapping screws (20-26mm) in the absence of this drill bit assembly. In compliance with this product recall, please examine your inventory and remove the above part numbers from your shelves. We ask you to send back the affected devices.
Athorized Representative/Importer/Distributor:Isam Economic Co., Riyadh, (01) 4600846
Report Source:NCAR
Source Ref. Number:CH-2012-08-31-047
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Synthes Inc.pdf