SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 072 10 15 000
Date submitted:	10/20/2015

Manufacturer:	Stryker Instruments.
Device Type:	Triathlon MIS Modular Distal Capture
Description:	Surgical instrument
Medical Device Identifier:	Catalog #: 6541-5-723
Reason of Field Safety Corrective Action:	Stryker has received customer complaints regarding Triathlon MIS Modular Distal Capture devices disassociating during use.
Remedy Action:	1. Immediately check your internal inventory and quarantine all subject devices. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Maintain awareness of this notice internally until all required actions have been completed within your facility.
Athorized Representative/Importer/Distributor:	Zimmo Trading Establishment.
Report Source:	NCMDR
Source Ref. Number:	3D25A846DB22B
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Stryker Instruments.pdf

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