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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 035 08 12 000
Orthopaedic Implantable device and material
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.
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
Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.