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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 107 06 12 000
Date submitted: 6/19/2012
Manufacturer:Zimmer inc
Device Type:Fixed Rod Holder Instruments, PathFinder NXT
Description:HOLDER, PathFinder NXT Spinal Pedicle Screw System
Medical Device Identifier:PathFinder NXT Fixed Rod Holder Instruments Part numbers 3573-1 (angle handle) and 3573-2 (straight handle); All lots
Reason of Field Safety Corrective Action:The tip of the rod holder may crack or break when the rod is manipulated during surgery.
Remedy Action:This notification is to inform Zimmer Spine Distributors and Sales Agents of the actions to take to notify surgeon customers of the issue and that a redesigned instrument with an improved tip is currently under development and will be provided, when available, to replace part numbers 3573-1 and 3573-2 (for more details see attached)
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:UK-2012-06-13-112
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer inc.pdf