CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report

Neodent GM Engaging Titanium Base recalled by Preat

Preat is recalling Neodent GM Engaging Titanium Base, distributed nationwide in the US. The recall was initiated on 21 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00842092161326, Lots: 211891 and 211912

Quantity recalled26

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1285-2023
FDA event ID: 91876
Recalling firm: Preat, Santa Maria, CA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Feb 2023
FDA classified: 24 Mar 2023
Reported: 5 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Feb 2023	Recall initiated by company
24 Mar 2023	Classified by FDA	+31 days
5 Apr 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

Where it was distributed

US Nationwide distribution in the states of TX, OR, UT, NY.

Nationwide New York Oregon Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 00842092161326, Lots: 211891 and 211912

Where was it sold?

US Nationwide distribution in the states of TX, OR, UT, NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Preat

All 11

Reported	Class	Recall	Company	Reason	Where
10 Sep 2025Device	CLASS II	NobelBiocare Tri-Lobe-compatible WP X Engaging Titanium Base recalled	Preat	Other	Nationwide
16 Jul 2025Device	CLASS II	Astra EV-compatible Digital Analog recalled by Preat	Preat	Other	Nationwide
25 Jun 2025Device	CLASS II	Biomet 3i Certain-compatible Milled Ti Abutment recalled by Preat	Preat	Other	Nationwide
28 Aug 2024Device	CLASS II	Multiple Digital Analog Products labeled as recalled by Preat	Preat	Potency & Assay	Nationwide
17 Jul 2024Device	CLASS II	9006767 Astra EV Milled Titanium Abutment Milled abutments recalled	Preat	Packaging Defects	CA, MO, NV

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