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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 047 09 11 000
Date submitted: 9/17/2011
Device Type:Hip prosthesis, Biolox OPTION Ceramic Femoral Head
Description:Hip prosthesis, internal, femoral component.
Medical Device Identifier:All reference numbers: 00-8777-028-01, 00-8777-028-02, 00-8777-028-03, 00-8777-028-04, 00-8777-032-01, 00-8777-032-02, 00-8777-032-03, 00-8777-032-04, 00-8777-036-01, 00-8777-036-02, 00-8777-036-03, 00-8777-036-04, 00-8777-040-01, 00-8777-040-02, 00-8777-040-03, 00-8777-040-04, 00-8778-028-01, 00-8778-028-02, 00-8778-028-03, 00-8778-032-01, 00-8778-032-02, 00-8778-032-03, 00-8778-036-01, 00-8778-036-02,00-8778-036-03, 00-8778-040-01, 00-8778-040-02, 00-8778-040-03
Reason of Field Safety Corrective Action:The manufacturer has determined that the current information as described in the Instructions for Use (IFU) and in the product brochure was confusing.
Remedy Action:The manufacturer has updated the text of the IFU and product information brochure. The revised IFU and a copy of the Field Safety Notice will be delivered with the implants in order to inform the surgeon.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:CH-2011-09-13-033
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments