Preat Corp recalls REF 9007123 Neodent GM x 4mm Healing Abutments (Rx Only) due to potential microleakage from gaps between abutment and implant. Affected units have UDI-DI: 00842092161388/Lot #OF018357.
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Preat Corp is recalling Neodent GM x 4mm Healing Abutments (Rx Only) because a dimensional issue might cause gaps between the abutment and dental implant, leading to microleakage. This could affect dental implants and requires replacement to prevent complications.
The healing abutments have a dimensional condition that may create a small gap between the abutment and the dental implant. This gap can allow microleakage, potentially causing infection or delayed healing in the implant site.
Dental patients with the recalled healing abutments (Rx Only, non-sterile, single-use) are most at risk. Patients using these abutments for dental implants should check if they have the specific model.
Check for the product name 'Neodent GM x 4mm Healing Abutment' with the UDI-DI code 00842092161388 and lot number OF018357. These are prescription-only dental implants sold by Preat Corp.
Verify the UDI-DI code 00842092161388 and lot number OF018357 on the abutment packaging.
The recall is due to a dimensional condition that may cause gaps between the abutment and dental implant, leading to microleakage.
Check for the UDI-DI code 00842092161388 and lot number OF018357 on the abutment packaging.
The recall does not require immediate stop-use; check product details to confirm if you have the recalled model.
We’ve drafted a message you can send Preat to request your refund or repair — edit it as you like.
Subject: Recall Z-0153-2024 — Preat Preat Hello, I own a Preat that is covered by recall Z-0153-2024 from Preat. 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.