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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 012 09 11 000
Date submitted: 9/5/2011
Manufacturer:Zimmer inc
Device Type:Joint prosthesis, MIS Setting Instrument
Description:Joint prosthesis implantation kit
Medical Device Identifier:MIS Setting Instrument for the pole plug for the Allofit/ Allofit IT Hip Cups. REF 01.00502.007, LOT 10524172.
Reason of Field Safety Corrective Action:The spring and washer to keep the pole plug in place are missing on the devices.
Remedy Action:Quarantine devices and return them to the local representative.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:CH-2011-08-16-029
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments