CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
NobelBiocare Tri-Lobe-compatible WP X Engaging Titanium Base recalled
Preat is recalling NobelBiocare Tri-Lobe-compatible WP X Engaging Titanium Base, distributed nationwide in the US. The recall was initiated on 25 Jun 2025 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-2514-2025
- FDA event ID
- 97239
- Recalling firm
- Preat, Santa Maria, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 3 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 3 Sep 2025 | Classified by FDA | +70 days |
| 10 Sep 2025 | Published in enforcement report | +7 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 was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
Product as listed by the FDA
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Where it was distributed
US Nationwide distribution in the states of NY, FL, PA, CA, OH.
Questions about this recall
Why was it recalled?
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
Which lots are affected?
UDI-DI: 00842092169599. Lot: 277097
Where was it sold?
US Nationwide distribution in the states of NY, FL, PA, CA, OH.
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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