Skip to content
Recall Observatory FDA recall evidence

Device product

3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.

Z-0535-2014

November 21, 2013

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 66944
Status
Terminated
Classification
Class II
Quantity
1977 kits
Official record key
device-enforcement:Z-0535-2014

Official wording

Reason: Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.

Code information: Lot codes: N510884, N510889, and N511952

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.