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 Preat 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

Lot, batch or date codesModel Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489

Quantity recalled561 units

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.

Nationwide Arizona Ohio Pennsylvania

Questions about this recall

Is Nobel Active/Conical-compatible RP Titanium Blank recalled?

Yes. Preat recalled Nobel Active/Conical-compatible RP Titanium Blank on 9 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1321-2024.

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 21 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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