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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 097 11 12 000
Date submitted: 11/24/2012
Manufacturer:Synthes Inc
Device Type:Femur nail, sterile, Trochanteric Fixation Nails
Description:Trochanteric Nail Kit, Fixation
Medical Device Identifier:Lot/batch no.: All, up to and inclusing 7060897 Part Number: See attached
Reason of Field Safety Corrective Action:The product is packaged in two pouches; a sterile, internal pouch within an external pouch. There is a potential for damage to the external pouch. The recall is being initiated due to the possibility that the outer pouch may be compromised.
Remedy Action:Synthes strongly urges you to return the identified devices and replacement product will be provided once it becomes available.
Athorized Representative/Importer/Distributor:Isam Economic Co., Riyadh, (01) 4600846
Report Source:NCAR
Source Ref. Number:CH-2012-11-19-071
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Synthes Inc.pdf