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 057 05 18 000
Date submitted:	5/13/2018

Manufacturer:	Smith & Nephew inc.
Device Type:	GII Tibial Punch
Description:	Prosthesis Implantation Instruments, Orthopedic
Medical Device Identifier:	Product No.: 71440408 Description: GENESIS II 13MM TIBIAL PUNCH Batch No. / UDI No.: 15FM16181 Shipment Dates: June 27, 2017 through December 11, 2017
Reason of Field Safety Corrective Action:	The affected trial punches are dimensionally incorrect; the affected punches are 2mm smaller than specification.
Remedy Action:	-Identify and quarantine the devices in your warehouse. -Identify and inform all users, which have received affected products with the attached Field Safety Notice for Recall. -Collect return slips of the Field Action Notice for Recall (to confirm awareness of all affected users) and forward them to the specified contact below. If acknowledgement is not provided by any of the affected users provide evidence of three attempts to notify these users. -Complete the acknowledgment section on page 3 and return it to the specified contact below. -Return collected devices as instructed in the attached FSN.
Athorized Representative/Importer/Distributor:	Smith & Nephew inc
Report Source:	NCMDR
Source Ref. Number:	5CF606D55A287
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Smith & Nephew inc..pdf

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