CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only recalled
Preat is recalling Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, distributed in 7 states. The recall was initiated on 18 Jul 2023 and the FDA has classified it as Class II.
Check your package
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-0154-2024
- FDA event ID
- 92867
- Recalling firm
- Preat, Santa Maria, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2023
- FDA classified
- 23 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 18 Jul 2023 | Recall initiated by company | |
| 23 Oct 2023 | Classified by FDA | +97 days |
| 1 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Where it was distributed
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Questions about this recall
Why was it recalled?
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Which lots are affected?
UDI-DI: 00842092161395/Lot #OF018355
Where was it sold?
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
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.
Other products in this recall event
2 other products · FDA event 92867This product is part of a recall event; the main page for the event is Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only recalled | Preat | Packaging Defects | 7 states | |
| CLASS II | Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only recalled | Preat | Packaging Defects | 7 states |
More recalls from Preat
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NobelBiocare Tri-Lobe-compatible WP X Engaging Titanium Base recalled | Preat | Other | Nationwide |
| Device | CLASS II | Astra EV-compatible Digital Analog recalled by Preat | Preat | Other | Nationwide |
| Device | CLASS II | Biomet 3i Certain-compatible Milled Ti Abutment recalled by Preat | Preat | Other | Nationwide |
| Device | CLASS II | Multiple Digital Analog Products labeled as recalled by Preat | Preat | Potency & Assay | Nationwide |
| Device | CLASS II | 9006767 Astra EV Milled Titanium Abutment Milled abutments recalled | Preat | Packaging Defects | CA, MO, NV |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |