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Medical Devices Sector
قطاع الأجهزة الطبية
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NCAR Recall
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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
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