Reported Aug 28, 2024 · Ongoing
Multiple Digital Analog Products labeled as
Preat Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Preat Corp · 2625 Skyway Dr Ste B · Santa Maria, CA · 93455-1405
Is this the product you have?
Multiple Digital Analog Products labeled as
13 of 13 products
| Model / number | Product as published |
|---|---|
9000703 | Straumann Tissue-Level-compatible WN Digital Analog |
9001303 | 3i Certain-compatible 5.0mm Digital Analog |
9001903 | 3i Certain-compatible 6.0mm Digital Analog |
9002003 | Astra-compatible 3.0mm Digital Analog |
9002103 | Astra-compatible Aqua 3.5/4.0mm Digital Analog |
9002203 | Astra-compatible Lilac 4.5/5.0mm Digital Analog |
9002203 | BioHorizons¿-compatible 3.0mm Digital Analog |
9005203 | Legacy-compatible 3.0mm Digital Analog |
9005303 | Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm |
9005403 | Legacy-compatible 3.5mm Digital Analog |
9005503 | Legacy-compatible 5.7mm Digital Analog |
9008503 | Astra EV 4.8mm Milled Titanium Abutment |
9006767 | Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory. |
- Lot codes and dates
- Model Numbers
90007039001303900190390020039002103900220390022039005203900520390053039005403900550390085039006767
- UDI-DI codes
00842092178690008420921818980084209218195900842092178737008420921787750084209217881200842092178812008420921788980084209217889800842092178997008420921789280084209217895900842092182130
- Lot Numbers
250219248890251432250602250418250213251459249071250335250223250336249510250215
- Model Numbers
- Amount recalled
- 185 devices
Where it was sold
Why it was recalled
Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Preat Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.