Recall Z-1822-2012 ยท KLE Agent, Tooth Bonding, Resin
Ultradent Products, Inc.
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delive
| Date | Jun 18, 2012 (initiated May 24, 2012) |
| Status | Terminated |
| Reason | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. |
| Root cause | Labeling mix-ups |
| Action | Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609. |
| Quantity | 172 kits (4 syringes per kit) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063558 | PEAK SE, MODEL 5135 Ultradent Products, Inc., Dec 14, 2006 |