3M Unitek Corporation recalls 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 u…

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

On 11/26/2024, the firm send an URGENT Product Recall letter via email to customers informing them that Solventum has received complaints of bracket bonding failures and skin irritation or blistering. Due to a manufacturing issue there is a potential for an increased occurrence of skin irritation/blistering and for reduced bracket bonding strength. Customer are instructed to: 1. Examine their inventory and destroy any affected product lots. Customers may dispose of the product per their facility s requirements. 2. Complete the enclosed Customer Product Acknowledgement Form and e-mail the completed form to 3MFieldSafetyAction@montage72.com. Upon receipt of the completed form, Solventum will issue replacement of product. For questions or further assistance - contact Montage customer service at 1-800-397-8118.

• FDA enforcement recordOfficial FDA database entry for Z-0797-2025
• FDA 510(k) clearance · K992048The device's official FDA premarket clearance record
• FDA device classification · KLEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find 3M Unitek CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.