Recall Z-0535-2014 ยท ELW Material, Impression
3M Company - Health Care Business
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 dentu
| Date | Dec 18, 2013 (initiated Nov 21, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | 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, c |
| Quantity | 1977 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK Espe Dental AG, Mar 30, 2000 |