AART recalls specific calf implant models (502-103 to 502-304) due to lack of FDA premarket approval. Consumers should check UDI-DI codes and lot numbers for affected items.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
AART is recalling calf implants with model numbers 502-103 to 502-304 because they were distributed without proper FDA premarket approval. This could pose health risks if used without regulatory clearance.
The recalled implants were distributed without obtaining required FDA premarket approvals or clearances. This means they may not meet safety standards, potentially leading to health risks if used in medical procedures without proper regulatory oversight.
Individuals who own or use the recalled calf implants (models 502-103 to 502-304) are affected. Medical professionals using these implants for procedures are at higher risk due to the lack of regulatory approval.
Check for model numbers 502-103 to 502-304 on the implant, along with UDI-DI codes (B490502103 to B490502304). Affected items also have specific lot numbers listed in the recall notice.
Identify the model number and UDI-DI code on the implant to confirm if it matches the recalled items.
The products were distributed without obtaining required FDA premarket approvals or clearances.
Check for model numbers 502-103 to 502-304 and UDI-DI codes B490502103 to B490502304 on the implant.
The recall notice does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send AART to request your refund or repair — edit it as you like.
Subject: Recall Z-0949-2026 — AART AART Hello, I own a AART that is covered by recall Z-0949-2026 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.
