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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 051 12 13 000
3M ESPE Dental Products
IMPRINT™ II Regular Body VPS Impression Material, PARADIGM™ Regular Body VPS Impression Material
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.
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.
Thimar Al Jazirah Healthcare Co., +966558311166
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.