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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 020 04 17 000
Date submitted: 4/5/2017
Manufacturer:Smith & Nephew
Device Type:Tecomet, OSTEOTOME BLADES
Medical Device Identifier:Product No.: ( 71369208, 71369210, 71369212, 71369220, 71369310, 71369312, 71369314, 71369316, 71369408, 71369410, 71369412, 71369420 )
Multiple batch numbers of the affected device are provided in the attached file.
Reason of Field Safety Corrective Action:The expiration dates printed on the labels are incorrect; the dates are after the actual expiration date of the sterilized package.
Remedy Action:1. Locate and quarantine affected unused devices immediately.
2. Return quarantined product to your national Smith & Nephew agency/distributor.
Athorized Representative/Importer/Distributor:Alhaya medical co.
Report Source:NCMDR
Source Ref. Number:1A17313E59F9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Smith & Nephew.pdf