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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 142 06 15 000
Java Hook Implants, Instruments, and Containers
Medical Device Identifier:
all part and lot numbers of Java Hook implants, instruments and containers See Attachment 1 for a complete list
Reason of Field Safety Corrective Action:
This recall is initiated due to lack of a steam sterilization validation to support the sterilization parameters stated in the Instructions For Use (IFU) (030EAN0000T and 030EAN0000I).
1. Review the notification and ensure affected personnel are aware of the contents.
2. Locate all affected product identified in Attachment 1 and quarantine them immediately.
3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 2).
Ebrahim M. Al-Mana & Bros. Co. Ltd.
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.