Home / Recalls / 3M Unitek Corporation / Z-0797-2025

Z-0797-2025 Class II Ongoing

Recalled by 3M Unitek Corporation — Monrovia, CA

FDA device recall Z-0797-2025 was initiated by 3M Unitek Corporation on November 26, 2024 and is designated Class II. Reason for recall: Due to an increase of complaints for bracket bond failures and skin irritation or blistering. The recall status is ongoing. Affected quantity: 5,873 boxes (380,180 individual L-pops).

Recall Details

Product Type: Devices
Report Date: January 8, 2025
Initiation Date: November 26, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,873 boxes (380,180 individual L-pops)

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.

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of : Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican, Republic, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Hong Kong, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherland, New Zealand, Norway, Poland, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, and the United Kingdom.

Code Information

Product Number: 712-090 UDI-DI code: 00652221109170 Lot Numbers: 11093917 11106533 11120254 11153742 11155372 11173412 Product Number: 712-091 UDI-DI code: 00652221109187 Lot Numbers: 11165780 11165793