FDA recall Z-1368-2022

Product

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.

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.

Key facts

Status

Completed

Initiation date

2022-06-01

Report date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2022