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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 056 12 11 001
Date submitted: 12/29/2012
Manufacturer:Smith & Nephew inc
Device Type:Bone Screws, TRIGEN INTERTAN Intertrochanteric Nails
Description:Screws, Bone
Medical Device Identifier:10GM03538 and 10GM05701 ............................................................................................................................... update: (NCMDR) 16-Dec-2012 (1) TRIGEN™ INTERTAN Intertrochanteric Antegrade Nail, 130 deg (1) Part Numbers: 71675210 (1) Lot Numbers: 12FT19274 (2) TRIGEN™ INTERTAN Intertrochanteric Antegrade Nail, 125 deg (2) Part Numbers: 71675204 (2) Lot Numbers: 12ET19095
Reason of Field Safety Corrective Action:Labeling error in such a way that these bone nails were marked with an incorrect angle (130° instead of 125° and vice versa)
Remedy Action:The users of devices have been informed about this recall according to manufacturer’s information. Furthermore, inspection procedure of Trigen Intertan nails has been improved and the staff (performing inspection) has been trained. Regarding patients with possibly implanted wrong devices the manufacturer sees no need for specific aftercare.
Athorized Representative/Importer/Distributor:Smith & Nephew inc, Dubai, 0097144299111
Report Source:NCAR
Source Ref. Number:DE-BfArM-2011-12-07-227
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments