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.
- Recall Initiated
- November 21, 2013
- Posted
- December 18, 2013
- Terminated
- June 2, 2014
- Recall Number
- Z-0535-2014
- Quantity
- 1977 kits
- Firm Location
- Saint Paul, MN
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
Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.
Lot / Code Info
Lot codes: N510884, N510889, and N511952
Root Cause
Employee error
Action Taken
3M ESPE sent an Voluntary Recall Notification Letter dated November 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to: 1) Review your inventory and identify any products from these lot numbers 2) Quarantine products from these lots and do not further distribute 3) If you have shipped any products from these lots to your customers, inform them of this voluntary recall using the attached Dear Doctor Letter and Inventory Checklist 4) To return and replace product from these lots, contact 3M ESPE Dental Products Customer Service at 1-800-237-1650 If you have any questions, please contact the above number for assistance. Once again, we sincerely apologize for any inconvenience this may cause you.