Recall Z-3215-2017 ยท EKN Point, Paper, Endodontic
Ultradent Products, Inc.
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
| Date | Aug 4, 2017 |
| Status | Terminated |
| Reason | The barcode label was placed underneath the sterile barrier and the product was re-wrapped. |
| Root cause | Process change control |
| Action | The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc. |
| Quantity | 95 units |
| Distribution | Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.