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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 048 10 11 000
Date submitted: 10/17/2011
Manufacturer:Biomet 3i Inc
Device Type:Dental implants supra structure device, permanent, Conical Angled Abutment, Standard Conical Abutment Cylinder
Description:Dental implants supra structure device, permanent
Medical Device Identifier:(1) Conical 25º Angled Abutment 4, 1mm(D) X 4mm (H) M/N: AC4425, L/N: 887628-5; (2) Conical Abutment Gold Standard ZR 6mm (D) X 2mm(H) M/N: SWCA62, L/N: 848478
Reason of Field Safety Corrective Action:The packaging for the products may have not been completely sealed prior to shipment.
Remedy Action:Return any unused product to BIOMET 3i using the following address and incident number. Upon receipt of your returned product, replacement product will be sent to you.
Athorized Representative/Importer/Distributor:Asnan Medical Services, Riyadh, (01) 4621613
Report Source:NCAR
Source Ref. Number:ES-2011-10-14-012
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments