3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etchin
FDA device recall Z-0797-2025 · posted 2025-01-02 · Open, Classified
Recall details
- Recalling firm
- 3M Unitek Corporation
- Reason for recall
- Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KLE
- Quantity affected
- 5,873 boxes (380,180 individual L-pops)
- Distribution
- 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,
- Date initiated
- 2024-11-26
- Date posted
- 2025-01-02
- Location
- Monrovia, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION OF PROMPT L-POP (K992048) | Espe Dental AG | 1999-08-16 |