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Preat Implant Prosthetics 9007162Recalls & reported problems

Preat Corporation · Neodent® GM™-compatible Engaging Ti Base X 6mm Kit Contains: 2 Neodent® GM™-compatible Titanium Screws 1 Neodent® GM™-compatible Engaging Ti Base X 6mm · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K220823); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 21, 2023Open, Classified

    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.

    Z-1285-2023 · Root cause: Process design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220823. One submission often covers many models, so check the product and lot details in each record.

  • Z-2107-2025 · Jun 24, 2025 · Open, Classified
    Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
  • Z-2318-2024 · Apr 10, 2024 · Open, Classified
    9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
  • Z-0153-2024 · Jul 18, 2023 · Open, Classified
    Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
  • Z-0152-2024 · Jul 18, 2023 · Open, Classified
    Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
  • Z-0154-2024 · Jul 18, 2023 · Open, Classified
    Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

Other Abutment, Implant, Dental, Endosseous devices

All Abutment, Implant, Dental, Endosseous devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.