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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 046 05 12 000
Date submitted: 5/20/2012
Manufacturer:DePuy International Limited
Device Type:CEMENT GUN
Description:Needles, Fire, Spinal, Cement
Medical Device Identifier:Product Code: 283904613, 283904411, 283904611, 283904413 Serial no: All Lot/batch no: All
Reason of Field Safety Corrective Action:This product is used to place bone cement in an Intra-vertebral fashion at a desired location. They come in a variety of lengths and diameters. The cement extrudes from the needle through a port on the side of the needle. The complaint rate for breakage of the Side Fire Needles was higher than the anticipated occurrence rate
Remedy Action:DePuy Spine is issuing a field correction to reinforce proper technique for the Side Fire Needles
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Middle East, Riyadh, Riyadh, (01) 4603292
Report Source:NCAR
Source Ref. Number:UK-2012-05-17-098
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments