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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 037 02 16 000
Date submitted: 2/14/2016
Manufacturer:Synthes Inc
Device Type:Universal Femoral Nails
Description:Intramedullary Nailing Implants
Medical Device Identifier:Part Description : SUN- Simplified Universal Femoral Nail, 0 11.0mm, Length 360mm, Stainless Steel Part Number : 272.136 Lot Numbers : 2126916

Part Description : Universal Femoral Nail 0 12.0mm, Length 380mm, Stainless Steel Part Number : 274.220 Lot Numbers : 2092149

Part Description : Universal Femoral Nail 0 10.0mm, Length 380mm, Stainless Steel Part Number : 274.020 Lot Numbers : 2075226

Part Description : Universal Femoral Nail 0 11.0mm, Length 400mm, Stainless Steel Part Number : 274.130 Lot Numbers : 2191091
Reason of Field Safety Corrective Action:It was discovered that the Universal Femoral Nails listed above, were not bent according to specifications.
Remedy Action:Return any affected product as soon as possible, but within 30 business days. A credit note will be issued for the returned items.
Athorized Representative/Importer/Distributor:Isam Economic Co.
Report Source:NCMDR
Source Ref. Number:6EA4750BD4266
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Synthes Inc.pdf