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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 107 06 12 000
Fixed Rod Holder Instruments, PathFinder NXT
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.
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)
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.