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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 001 04 15 000
Date submitted: 4/2/2015
Manufacturer:Nobel Biocare
Device Type:Nobel dental implant, NobelReplace
Description:Dental implant
Medical Device Identifier:Multiple material numbers & Lot numbers are provided in the attached FSN
Reason of Field Safety Corrective Action:Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. Their internal analysis has confirmed that this material is not according to their standards.
Remedy Action:Nobel Biocare requested customers to return affected products that have not yet been used to Nobel Biocare to receive a replacement product.
Athorized Representative/Importer/Distributor:Al-Turki Medical Group Ltd (AMG)
Report Source:NCMDR
Source Ref. Number:754555A64C201
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Nobel Biocare.pdf