AART Malar Implant model 401-202-5 and 401-202-6 were recalled due to FDA approval issues. The products were distributed without required premarket approvals.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
AART Malar Implant models 401-202-5 and 401-202-6 were recalled because they were distributed without the required FDA premarket approvals. This means the products may not meet safety standards.
The products were distributed without the required FDA premarket approvals or clearances. This means they may not meet safety standards, but the exact risk is not specified in the recall notice.
Patients who received the AART Malar Implant models 401-202-5 or 401-202-6 are likely affected. Those with the specific lot numbers 24-01-014 or 24-01-015 are at higher risk.
Check for model numbers 401-202-5 or 401-202-6 with UDI-DI codes B4904012025 or B4904012026. Lot numbers 24-01-014 or 24-01-015 are also associated with these products.
Identify the model number and UDI-DI code on the implant to confirm if it matches the recalled items.
The products were distributed without the required FDA premarket approvals or clearances.
Models 401-202-5 and 401-202-6 with UDI-DI codes B4904012025 or B4904012026.
The recall notice does not specify a remedy, so contact the manufacturer for further instructions.
We’ve drafted a message you can send AART to request your refund or repair — edit it as you like.
Subject: Recall Z-0947-2026 — AART AART Hello, I own a AART that is covered by recall Z-0947-2026 from AART. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
