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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 142 06 15 000
Date submitted: 6/24/2015
Manufacturer:Zimmer inc
Device Type:Java Hook Implants, Instruments, and Containers
Description:Implants, Instruments
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).
Remedy Action: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).
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd.
Report Source:NCMDR
Source Ref. Number:By_E-mail
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer inc.pdf