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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 093 11 12 000
Date submitted: 11/21/2012
Manufacturer:Biomet 3i Inc
Device Type:Dental implant, Full OSSEOTITE Parallel Walled Certain® Implant and Full OSSEOTITE® 2 Tapered Certain® Implant
Description:Dental Implant, endosseous
Medical Device Identifier: Lot/batch no.: 2011111333, 2011111333-S1 (model IFOS411) 2012040462 (model XIFNT413)
Reason of Field Safety Corrective Action: A small number of implants from the above referenced lot number may contain a manufacturing condition where the depth of the implant’s internal hex is too shallow. The condition, if present, may prevent the driver or abutment from fully engaging the implant.
Remedy Action: BIOMET 3i is requesting that you return the item(s) for replacement if you have not already opened the implant package. If you have opened the package and attempted to engage the driver with an implant having the shallow hex condition, it is likely that you and/or your staff would have recognized the issue immediately since it’s unlikely that the driver would’ve fully engaged the implant. In this case, we also ask that you return the unused product for replacement.
Athorized Representative/Importer/Distributor:Asnan Medical Services, Riyadh, (01) 4621613
Report Source:NCAR
Source Ref. Number:ES-2012-11-14-009
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments