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.
Check against the official notice below — it lists the full affected range.
Ultradent Products, Inc. is recalling Peak Universal Bond Self-Etch products because the SE primer in these kits may be missing some or all of the resin portion of the chemistry. Without the resin component, the primer may not bond properly and could result in weak or failed restorations. The affected products include Peak Universal Bond Self-Etch Bottle Kits (Part 4541), Peak Universal Bond Self-Etch Intro Kits (Part 4554), Peak SE Primer 4pk Refills (Part 5135), and Peak Universal Bond Sample Kits (Part S4554), affecting 1,331 kits totaling 5,009 syringes distributed worldwide and in multiple U.S. states.
The recall involves specific lot numbers for each product, which are identified by reference numbers such as BLRCR, BM1Y7, and BM9G3 for Part 4541; BLSGH, BM578, and BN449 for Part 4554; and several lot numbers for Parts 5135 and S4554. The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 1331 Kits (5009 Syringes) Lot/code info: REF/ UDI-DI/ Lot: 4541/ 00883205104274/ BLRCR, BM1Y7, BM9G3; 4554/ 00883205104281/ BLSGH, BM578, BN449; 5135/ 00883205104311/ BLX3F, BLSGM, BLXSG, BLXW4, BM34M, BM784, BM9KB, BMJVK, BMTZM; S4554/ 00883205102065/ BLRJJ, BM1NH
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.