WhichRecall
Class IIReported 2025-12-24

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026

Recalled by DSAART LLC

Reason for Recall

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

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Recall Number
Z-0947-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-09-26
Reported
2025-12-24
Distribution
U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI O.U.S.: N/A
Code Info
Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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