Preat Corp recalls Neodent GM X 6mm Engaging Titanium Base (REF 9007162) due to potential abutment/screw fracture from improper installation, risking ingestion by patients.
Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
Preat Corp is recalling Neodent GM X 6mm Engaging Titanium Bases with specific reference numbers because a manufacturing defect could cause the base to move after installation, potentially leading to fractures that might be swallowed by the patient. This is serious because dental implants are critical for oral health and swallowing fractures could cause severe injury.
The titanium base can move vertically after being tightened to the correct torque, which may not be detected during installation. If this movement occurs without being noticed, it could cause the base, screw, or crown to break off and be swallowed by the patient, leading to serious injury.
Dental patients who have recently installed the Neodent GM X 6mm Engaging Titanium Base with reference numbers 9007162, lots 211891 or 211912 are most at risk. Patients with dental implants using this specific base are affected.
Check for the reference number 9007162 on the Neodent GM X 6mm Engaging Titanium Base. The product was sold with specific lots: 211891 and 211912.
Verify if the titanium base was tightened to the recommended torque during installation, as improper tightening could cause movement.
Yes, the recall states that if the base moves after installation without being detected, it could lead to fractures that might be swallowed by the patient, causing serious injury.
The recall does not specify a remedy, so you should check if the base was installed correctly and contact your dentist for advice.
Look for the reference number 9007162 on the Neodent GM X 6mm Engaging Titanium Base, which was sold with lots 211891 or 211912.
We’ve drafted a message you can send Preat Corp to request your refund or repair — edit it as you like.
Subject: Recall Z-1285-2023 — Preat Corp Preat Corp Hello, I own a Preat Corp that is covered by recall Z-1285-2023 from Preat Corp. 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.
