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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 035 08 12 000
Date submitted: 8/14/2012
Manufacturer:Zimmer inc
Device Type:Orthopaedic Implantable device and material
Description:Orthopaedic Implants
Medical Device Identifier:Several products (Implants) manufactured by Winterthur site before March 2010
Reason of Field Safety Corrective Action:In rare cases, product information on the patient label, with respect to REF number! LOT number might not coincide with the corresponding information on the product label. While the information printed on the product label is always correct. the information on the patient label (in rare cases) may be wrong.
Remedy Action:Check the patient label by comparing its information to the product label during the surgery. However if the patient label should not match with the product label, we kindly ask you to follow these instructions: (1) Use whatever your institutional protocol is to manually record patient information using the correct information contained on the outer box label; (2) Report the error to Zimmer
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:CH-2012-08-06-042
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer inc.pdf