CLASS II ONGOING Device recall · Reported 17 Jul 2024 · FDA Enforcement Report
9006767 Astra EV Milled Titanium Abutment Milled abutments recalled
Preat is recalling 9006767 Astra EV Milled Titanium Abutment Milled abutments are too be used in conjunction, distributed in California, Missouri, Nevada. The recall was initiated on 10 Apr 2024 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-2318-2024
- FDA event ID
- 94693
- Recalling firm
- Preat, Santa Maria, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Apr 2024
- FDA classified
- 8 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 10 Apr 2024 | Recall initiated by company | |
| 8 Jul 2024 | Classified by FDA | +89 days |
| 17 Jul 2024 | 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
Due to incorrect milled titanium abutment being packaged and labeled.
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
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.
Where it was distributed
U.S.: CA, MO, and NV. O.U.S.: None
Questions about this recall
Why was it recalled?
Due to incorrect milled titanium abutment being packaged and labeled.
Which lots are affected?
Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Where was it sold?
U.S.: CA, MO, and NV. O.U.S.: 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.
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|---|---|---|---|---|---|
| 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 | Nobel Active/Conical-compatible RP Titanium Blank recalled by Preat | Preat | Other | Nationwide |
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|---|---|---|---|---|---|
| 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 |