AART recalls gluteal implants with model numbers 501-101 to 501-310 due to FDA approval issues. Consumers should check UDI-DI codes for affected products.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
AART is recalling gluteal implants with specific model numbers and UDI-DI codes because they were distributed without proper FDA premarket approvals. This could pose risks if used without the required regulatory clearances.
The implants were distributed without obtaining necessary FDA premarket approvals or clearances. This means they may not meet safety standards, potentially leading to complications during or after surgery.
Individuals who purchased or received AART gluteal implants with the listed model numbers and UDI-DI codes are affected. Patients undergoing surgical procedures with these implants are at the highest risk.
Check the UDI-DI code on the implant packaging. Affected products have codes like B490501101, B490501103, and others listed in the recall notice. Also, verify the model numbers and lot numbers provided in the recall details.
Review the UDI-DI code, model number, and lot number on the implant packaging to confirm if it matches the recalled items.
The products were distributed without obtaining the required FDA premarket approvals or clearances, which may affect their safety.
Look for the UDI-DI code on the packaging. Affected products have specific codes like B490501101, B490501103, and others listed in the recall notice.
The recall does not specify a stop-use instruction; the remedy is null, so users should check if their 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-0945-2026 — AART AART Hello, I own a AART that is covered by recall Z-0945-2026 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.
