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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 038 10 11 000
Date submitted: 10/15/2011
Manufacturer:Fin-Ceramica Faenza
Device Type:Bone matrix implant, synthetic, FINblock and SINTlife
Description:Bone matrix implant, synthetic
Medical Device Identifier:(1) FINblock: all those distributed since January 1 2006; (2) SINTlife: all distributed since January 1 2009 with expiry date until December 2011
Reason of Field Safety Corrective Action:Case of abnormal use of bone filler named FINblock and SINTlife.
Remedy Action:Finceramica intend modify the Ifu ( Instructions for use) of FINblock and specify the need to strictly follow the SINTlife instructions for use.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:IT-2011-09-16-001
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments