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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 073 07 11 000
Date submitted: 7/18/2011
Manufacturer:DePuy International Limited
Device Type:Surgical instruments, implant: drill guide, Mountaineer OCT System Screw Caddy
Description:Surgical instruments, implant: drill guide
Medical Device Identifier:Mountaineer OCT System Screw Caddy, Model No.: 2883-90-000
Reason of Field Safety Corrective Action:The manufacturer has determined that the scale which serves as a secondary means of identifying screw length is incorrectly etched on the product. If the screw is placed in the wrong caddy slot and then used in surgery there is the possibility of the screw penetrating too deeply into the targeted vertebrae.
Remedy Action:A design error was identified as being the root cause and a new design has been implemented.
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
Report Source:NCAR
Source Ref. Number:UK-2011-07-13-091
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments