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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 042 01 11 000
Date submitted: 1/18/2011
Manufacturer:Biomet 3i Inc
Device Type:OsseoTite®Certain®Implant
Description:Dental implant endosseous
Medical Device Identifier:OsseoTite Certain Implant 5X 11.5 mm Model IOSS511 , Lot/batch no. 910695
Reason of Field Safety Corrective Action:(January 17 , 2011 )The implant(s) may contain a manufacturing defect. This condition may be present in a small percentage of the lot 910695 and it relates to a shallow depth of the internal hex. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant. A complaint was received from a customer and the investigation showed that an incorrect machine tool was used during the manufacturing of the product and that related inspection protocols weren’t adequately followed.
Remedy Action:Remove from the market the unused units of the affected lot.
Athorized Representative/Importer/Distributor:Asnan Medical Services , Riyadh , (01) 4621613
Report Source:http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
Source Ref. Number:ES-2011-01-17-001
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments