Reported Dec 25, 2013 · Terminated
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression…
3M Company - Health Care Business
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: 3M Company - Health Care Business · 3M Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN · 55144
Is this the product you have?
- 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.
- Lot codes and dates
- Lot codes
N510884N510889and N511952
- Lot codes
- Amount recalled
- 1977 kits
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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