Recall Z-0797-2025— 3M Unitek Corporation

Name: FDA recall Z-0797-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-26

Class II · Ongoing

Class II FDA medical device recall by 3M Unitek Corporation, initiated 2024-11-26. It names one FDA 510(k) clearance: K992048. Product: 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.. Reason: Due to an increase of complaints for bracket bond failures and skin irritation or blistering..

Recalling firm: 3M Unitek Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-11-26
Firm location: Monrovia, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K992048 — MODIFICATION OF PROMPT L-POPEspe Dental AG·cleared 1999-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.

Reason for recall

Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

Data sourced from openFDA. This site is unofficial and independent of the FDA.