Recall Z-1368-2022 ยท KLE Agent, Tooth Bonding, Resin
Ultradent Products, Inc.
Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use in light-curing dental bonding procedures.
| Date | Jun 1, 2022 |
| Status | Completed |
| Reason | SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer. |
| Root cause | Device Design |
| Action | On 06/01/22, recall notices were mailed to customers who were asked to do the following: 1) Discard all primers inside affected devices. 2) Complete and return the recall notice response form. Customers with questions regarding product credit may call Customer Service at 1-888-2301420. Customers with questions or concerns related to the primer can contact Customer Concerns at 801-553-4139. |
| Quantity | 1331 Kits (5009 Syringes) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Florida, Michigan, Nevada, Washington, Colorado, Virginia, Puerto Rico, Wisconsin, Iowa, Tennessee, Arkansas, Minnesota, Wyoming, Maine and the countries of Kuwait, Italy, France, Canada, Spain, Malaysia, Russia, Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063558 | PEAK SE, MODEL 5135 Ultradent Products, Inc., Dec 14, 2006 |