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.
FDA Recall Z-1368-2022 · Posted None
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Recalling FirmUltradent Products, Inc.
Recall StatusCompleted
Product CodeKLE
Date Initiated2022-06-01
Product Quantity1331 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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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