Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Prime
Summary
The FDA issued a Class II for Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-E by Ultradent Products, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-1368-2022
Action Date
2022-07-20
Status
Completed
Category
device
Product Description
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.
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
Quantity Affected: 1331 Kits (5009 Syringes)
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-01
Company
South Jordan, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ultradent Products, Inc. has 12 FDA actions in our database, including 5 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ultradent Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ultradent Products, Inc. have FDA actions?
Ultradent Products, Inc. has 12 FDA actions in our database, including 5 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1368-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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