CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
Nobel Active/Conical-compatible RP Titanium Blank recalled by Preat
Preat is recalling Nobel Active/Conical-compatible RP Titanium Blank, distributed nationwide in the US. The recall was initiated on 9 Feb 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-1321-2024
- FDA event ID
- 94032
- Recalling firm
- Preat, Santa Maria, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2024
- FDA classified
- 20 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2024 | Recall initiated by company | |
| 20 Mar 2024 | Classified by FDA | +40 days |
| 27 Mar 2024 | 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
Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
Product as listed by the FDA
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Where it was distributed
U.S. Nationwide distribution in the states of AZ, OH and PA.
Questions about this recall
Why was it recalled?
Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
Which lots are affected?
Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489
Where was it sold?
U.S. Nationwide distribution in the states of AZ, OH and PA.
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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