3M Company - Health Care Business: Medical Device Recall in 2013 - (Recall #: Z-0535-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 21, 2013

Date Posted: December 25, 2013

Recall Number: Z-0535-2014

Event ID: 66944

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1977 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated