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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 071 07 12 000
Date submitted: 7/18/2012
Manufacturer:Biomet 3i Inc
Device Type:Low Profile Abutment Hexed Castable Cylinder
Description:Dental implants,Abutment Hexed Castable Cylinder
Medical Device Identifier: Model LPCCC1 Lot/batch no: 2010100001, 2010080684 and 2010090191
Reason of Field Safety Corrective Action: Some packages labeled LPCCC1, Hexed Castable Cylinder may contain LPCCC2, Non-Hexed Castable Cylinder
Remedy Action:Return any unused quantity for replacement
Athorized Representative/Importer/Distributor:Asnan Medical Services, Riyadh, (01) 4621613
Report Source:NCAR
Source Ref. Number:ES-2012-07-11-004
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments