SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall

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Reference Number:	mdprc 077 03 15 000
Date submitted:	3/17/2015

Manufacturer:	DePuySynthes
Device Type:	PFNA-II Proximal Femoral Nail Diameter 10 mm, PFNA-II Proximal Femoral Nail Diameter 9 mm,
Description:	Femur nail, sterile
Medical Device Identifier:	Trade Name , Part No./ Lot No. : - PFNA-II Proximal Femoral Nail Diameter 10 mm Length 200mm, 472.115S/ 8711483 - PFNA-II Proximal Femoral Nail Diameter 10 mm Length 170mm, 472.390S/ 8749027 - PFNA-II Proximal Femoral Nail Diameter 9 mm Length 200mm, 472.114S/ 8726113 - PFNA-II End Cap, Extension, 0 mm , 473.170S/ 8955101
Reason of Field Safety Corrective Action:	It was discovered that the above part and lot numbers may have the incorrect anodized color.
Remedy Action:	Synthes will remove the affected lots from the field as a corrective action.
Athorized Representative/Importer/Distributor:	Isam Economic Co., Riyadh, (011) 4600846
Report Source:	NCAR
Source Ref. Number:	CH-2015-03-16-018
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Vk_20150313_06-e1.pdf

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