Z-0947-2026 Class II Ongoing
FDA device recall Z-0947-2026 was initiated by DSAART LLC on Sep 26, 2025 and is designated Class II. Reason for recall: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. The recall status is ongoing. Affected quantity: 2 implants.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 24, 2025
- Initiation Date
- Sep 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 implants
Product Description
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
Reason for Recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Distribution Pattern
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 Information
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
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0947-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026