Preat Implant Prosthetics 9007121Recalls & reported problems

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. Jul 18, 2023Open, Classified

   The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

   Z-0152-2024 · Root cause: Process change control · 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-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
• Z-1285-2023 · Feb 21, 2023 · Open, Classified
  Neodent GM X 6mm Engaging Titanium Base, REF: 9007162