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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
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ational
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enter for
M
edical
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evices
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eporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
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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
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