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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 005 10 13 000
Bone rasp , optimys Opening Broach bent
Orthopaedic surgery tools , Bone rasp , optimys Opening Broach bent
Medical Device Identifier:
Article number: 51.34.0079 Lot numbers: 6053731, 6054883, 6057918, 6059150, 6060683
Reason of Field Safety Corrective Action:
Mathys Ltd Bettlach (Mathys) has been notified of an incident in where the optimys Opening Broach broke intraoperatively and the fragment was left in the bone. Investigations have shown that the instrument was not used in compliance with the instructions, and detailed exploration revealed that this was causal to the incident. In the course of the investigations, it became apparent that the Opening Broach bent may exhibit surface defects in the hewn portion which may favor breakage in case of non-compliant usage
Please read this Field Safety Notice carefully. And replacement products made of material more suitable for the field of application are currently being manufactured. As soon as they become available ,manufacture will inform you and arrange for the replacement at your hospital.
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.