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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 051 12 13 000
Date submitted: 12/5/2013
Manufacturer:3M ESPE Dental Products
Device Type:IMPRINT™ II Regular Body VPS Impression Material, PARADIGM™ Regular Body VPS Impression Material
Description:Crown and bridge impressions, Inlay and onlay impressions, Functional impressions, Denture and partial denture impressions
Medical Device Identifier:IMPRINT™ II Regular Body VPS Impression Material Refill 4-PACK Catalog Number 9379, Lot Codes N510884 and N510889
PARADIGM™ Regular Body VPS Impression Material Refill 2-PACK Catalog Number 5315, Lot Code N511952
Reason of Field Safety Corrective Action:The ingredient that gives hydrophilic properties to this impression material was left out of the formulation. The two different trade names and corresponding lot numbers are listed above.
Remedy Action: All 3M Distributors and individual customers to whom affected product was shipped will be notified via e-mail and/or phone call, using customer sales records/data. Letters explaining the reason and scope of the recall will be sent to Distributors and Customers who received this product. Customers will receive replacement product upon request.
Athorized Representative/Importer/Distributor:Thimar Al Jazirah Healthcare Co., +966558311166
Report Source:NCMDR
Source Ref. Number:1CF3D583A330A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: 3M.pdf