Z-0535-2014 Class II Terminated
FDA device recall Z-0535-2014 was initiated by 3M Company - Health Care Business on Nov 21, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 2, 2014). Affected quantity: 1977 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 25, 2013
- Initiation Date
- Nov 21, 2013
- Termination Date
- Jun 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1977 kits
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.
Code Information
Lot codes: N510884, N510889, and N511952
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0535-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026