Device Recall Imprint II and Paradigm impression material 의 리콜

Recall

66944

Class 2

Z-0535-2014

2013-11-21

2013-12-18

Terminated

United States

2014-06-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124262

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.

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.