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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 051 11 11 000
Date submitted: 11/11/2011
Manufacturer:Stryker
Device Type:Solis Trial Cage
Description:Solis Trial
Medical Device Identifier:Catalog Num: 8741206 8741209 - 8741404 - 8741406 - 8741407 Lot Num: 091854 - 10G655 - 10G757 - 10F956 - 08C688
Reason of Field Safety Corrective Action:The hole used to thread the solis trial into the implant holder was manufactured on the left side of the instrument instead of the right as indicated on the engineering print,this leads to the trial being placed upside down on the handle
Remedy Action:Immediately locate and quarantine all subjects devices
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh, (01) 4041717
Report Source:NCMDR
Source Ref. Number:8737E4335A22F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments