Z-2687-2024Class II

Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF...

Name: Z-2687-2024 Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF...
Creator: Preat Corp
Published: 2024-06-25
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2024-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital... on 2024-06-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2687-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-25
Posted: 2024-08-19
Recalling firm: PREAT Corporation
Product: 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.
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 07/22/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter via certified mail informing customers that Digital Analogs were manufactured out of specification for the rotational feature which may result in the dental restoration/implant may be slightly different than the position of the actual implant in the patient's mouth. Customers are instructed to: Product in the scope of this recall should be discarded or returned to PREAT CORPORATION. For questions contact Quality Regulatory Affairs at 224-622-7191 or email [email protected]
Quantity in commerce: 185 devices
Distribution: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2687-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2687-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-19

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)