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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 140 05 18 000
Date submitted: 5/30/2018
Manufacturer:DePuy International Limited
Device Type:CORAIL AMT Neck Trials Surgical Instruments
Description:Non-active implantable devices
Medical Device Identifier:L94003 - L94004 - L94005 - L94006 - L94007
Reason of Field Safety Corrective Action:A series of complaints have been received regarding debris/material being found behind the O-rings for the Corail Neck Trials. This was evaluated through Product Impact Assessment (PIA 1125328) which concluded that this issue does not present any additional risk to the patient. However, as the ongoing investigation requires the completion of a cleaning verification study, it was considered necessary to implement interim corrective actions. The need for this has been re-iterated through discussions with the Irish Health Authority (HPRA).
Remedy Action:As a precautionary measure, the company determined that reworking the affected devices and removing the O-Rings is the appropriate corrective action. The function of the device is unaffected by this change as DePuy currently markets products of the same design (i.e. without an O-Ring). This Field Safety Notice provides instructions for notifying medical facilities that may have used, purchased, or received the affected units. The purpose of this Field Safety Corrective Action is to alert medical facilities of the rework plan to remove the O-Ring from the affected devices.
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Meddile East
Report Source:NCMDR
Source Ref. Number:B4BBBB0247273
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: DePuy International Limited.pdf