CLASS II ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report

Multiple Digital Analog Products labeled as recalled by Preat

Preat is recalling Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible Digital, distributed nationwide in the US. The recall was initiated on 25 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled185 devices

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-2687-2024
FDA event ID: 94933
Recalling firm: Preat, Santa Maria, CA
Classification: Class II
Status: Ongoing
Recall initiated: 25 Jun 2024
FDA classified: 19 Aug 2024
Reported: 28 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Dental Devices

Timeline

25 Jun 2024	Recall initiated by company
19 Aug 2024	Classified by FDA	+55 days
28 Aug 2024	Published in enforcement report	+9 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 product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

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

Nationwide Alaska Arizona Florida Georgia Illinois Louisiana Maryland Michigan Minnesota New York Ohio Oklahoma Oregon Pennsylvania Rhode Island Texas Utah Washington

Questions about this recall

Why was it 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.

Which lots are affected?

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.

Where was it sold?

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

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.

More recalls from Preat

All 11

Reported	Class	Recall	Company	Reason	Where
10 Sep 2025Device	CLASS II	NobelBiocare Tri-Lobe-compatible WP X Engaging Titanium Base recalled	Preat	Other	Nationwide
16 Jul 2025Device	CLASS II	Astra EV-compatible Digital Analog recalled by Preat	Preat	Other	Nationwide
25 Jun 2025Device	CLASS II	Biomet 3i Certain-compatible Milled Ti Abutment recalled by Preat	Preat	Other	Nationwide
17 Jul 2024Device	CLASS II	9006767 Astra EV Milled Titanium Abutment Milled abutments recalled	Preat	Packaging Defects	CA, MO, NV
27 Mar 2024Device	CLASS II	Nobel Active/Conical-compatible RP Titanium Blank recalled by Preat	Preat	Other	Nationwide

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2 Sep 2026Device	CLASS II	Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled	Henry Schein	Packaging Defects	Nationwide
19 Aug 2026Device	CLASS II	GM Helix Implant, Endosseous Dental Implant Article No. recalled	Straumann USA	Packaging Defects	Nationwide
15 Jul 2026Device	CLASS II	KL Owen Custom Orthodontic Solution recalled by Klowen Braces	Klowen Braces	Device Malfunction	Nationwide
6 May 2026Device	CLASS II	Straumann n!ce PMMA Full-arch Restoration recalled	Straumann USA	Other	8 states
6 May 2026Device	CLASS II	Straumann n!ce Zr, HT, Full-arch Restoration recalled	Straumann USA	Other	8 states