AART recalls chin implants with model numbers 400-0101 to 400-0302 that were distributed without required FDA premarket approvals. Consumers should check their product details to ensure safety.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
AART is recalling chin implants with specific model numbers because they were distributed without the necessary FDA premarket approvals. This could pose health risks if used without proper regulatory clearance.
The implants were distributed without the required FDA premarket approvals or clearances. This means they may not meet safety standards, potentially leading to health risks if used without proper regulatory oversight.
People who own or use the recalled chin implants with model numbers 400-0101 to 400-0302 are affected. Those who have these implants without FDA approval are at risk of health issues.
Check for model numbers 400-0101 to 400-0302 on the implant packaging. The UDI-DI codes (B490400101 to B490400302) and specific lot numbers are also indicators of the recalled items.
Identify the model number and UDI-DI code on your chin implant to see if it matches the recalled items.
The products were distributed without the required FDA premarket approvals or clearances, which may pose health risks.
Model numbers 400-0101 to 400-0302 with specific UDI-DI codes and lot numbers are affected.
The recall does not specify a stop-use instruction, so you should check if your product is affected before taking action.
We’ve drafted a message you can send AART to request your refund or repair — edit it as you like.
Subject: Recall Z-0946-2026 — AART AART Hello, I own a AART that is covered by recall Z-0946-2026 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.
