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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 188 09 12 000
Date submitted: 9/30/2012
Manufacturer:Biomet 3i Inc
Device Type:Dental Implant, endosseous, Osseotite Tapered Certain Implant
Description:Dental Implant, endosseous
Medical Device Identifier:Product: INT510; Lot #: 2011090751
Reason of Field Safety Corrective Action:A very small percentage of the above implant lots may be missing the internal threading.
Remedy Action:If you have unused product, return the product(s) to BIOMET 3i.
Athorized Representative/Importer/Distributor:Asnan Medical Services, Riyadh, (01) 4621613
Report Source:NCAR
Source Ref. Number:ES-2012-09-20-007
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments