Intersect ENT recalls Propel Mini Mometasone Furoate Sinus Implant with incorrect product label. This affects specific model numbers and lot numbers. Consumers should check their product details.
Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Intersect ENT is recalling a specific type of sinus implant due to incorrect product labeling on the packaging. This means the product might not be the right version for patients, which could lead to improper use or safety issues.
The product label shows incorrect information, including the wrong reference number and UDI-DI. This could mean the implant isn't the correct version for the patient, potentially leading to improper use or safety concerns.
People who own or use the Propel Mini Mometasone Furoate Sinus Implant with Straight Delivery System, reference number 60044. Those most at risk are patients who have received this specific implant.
Check for the product name 'Propel Mini Mometasone Furoate Sinus Implant' with Straight Delivery System. Look for reference number 60044, UDI-DI M927600440, and lot number 22041901.
Review the product label for reference number 60044, UDI-DI M927600440, and lot number 22041901.
No, the recall is due to incorrect labeling, not a safety hazard. The product itself is safe but needs the correct label information.
Check for reference number 60044, UDI-DI M927600440, and lot number 22041901 on the product label.
Review the product label for the specific reference and lot numbers. If it matches, contact Intersect ENT for further instructions.
We’ve drafted a message you can send Intersect ENT to request your refund or repair — edit it as you like.
Subject: Recall Z-0458-2023 — Intersect ENT Intersect ENT Hello, I own a Intersect ENT that is covered by recall Z-0458-2023 from Intersect ENT. 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.
