Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Model Numbers: 9000703, 9001303, 9001903, 9002003, 9002103, 9002203, 9002203, 9005203, 9005203, 9005303, 9005403, 9005503, 9008503, 9006767 UDI-DI codes: 00842092178690, 00842092181898, 00842092181959, 00842092178737, 00842092178775, 00842092178812, 00842092178812, 00842092178898, 00842092178898, 00842092178997, 00842092178928, 00842092178959, 00842092182130 Lot Numbers: 250219, 248890, 251432, 250602, 250418, 250213, 251459, 249071, 250335, 250223, 250336, 249510, 250215.
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
U.S. Nationwide distribution in the states of AK, AZ, FL, GA, IL, LA, MD, MI, MN, NY, OH, OK, OR, PA, RI, TX, UT, and WA
Recall record
- Recalling firm
- Preat Corp
- Product type
- Devices
- Recall number
- Z-2687-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Santa Maria, CA
- Recall initiated
- 2024-06-25
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2687-2024 · Source: openFDA enforcement.