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Medical Devices Sector
قطاع الأجهزة الطبية
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NCAR Recall
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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
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