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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Preat Corp: Digital Analog Dental Products Recalled Due to Manufacturing Defect

Agency Publication Date: August 19, 2024
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Summary

Preat Corp is recalling 185 units of several Digital Analog dental products because a manufacturing issue caused these parts to rotate out of their required specifications. These components are used by dental laboratories to visually inspect abutments and restorations; if the part rotates incorrectly, it can lead to inaccurate dental fittings. Consumers and dental professionals should contact the manufacturer immediately regarding the affected models, which include various NobelBiocare, Straumann, 3i Certain, Astra, BioHorizons, and Legacy compatible analogs.

Risk

A manufacturing defect causes the digital analog to rotate beyond its intended range. This out-of-specification rotation can result in the misalignment or improper visual inspection of dental abutments and restorations, potentially leading to poorly fitting dental prosthetics.

What You Should Do

  1. Identify if you have any of the affected digital analog products by checking the packaging for the following Reference (REF) or Model numbers: 9000703, 9001303, 9001903, 9002003, 9002103, 9002203, 9005203, 9005303, 9005403, 9005503, 9008503, or 9006767.
  2. Verify the Lot Number on the product label against the following affected lots: 250219, 248890, 251432, 250602, 250418, 250213, 251459, 249071, 250335, 250223, 250336, 249510, or 250215.
  3. Check the UDI-DI barcode on the packaging to see if it matches any of these codes: 00842092178690, 00842092181898, 00842092181959, 00842092178737, 00842092178775, 00842092178812, 00842092178898, 00842092178997, 00842092178928, 00842092178959, or 00842092182130.
  4. Immediately contact your healthcare provider or Preat Corp at the distributor location at 2625 Skyway Dr Ste B, Santa Maria, California, 93455-1405, for further instructions on returning or replacing the affected devices.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Manufacturer instructions via letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog
Model / REF:
9000703
UPC Codes:
00842092178690
Lot Numbers:
250219
Product: Straumann Tissue-Level-compatible WN Digital Analog
Model / REF:
9001303
UPC Codes:
00842092181898
Lot Numbers:
248890
Product: 3i Certain-compatible 5.0mm Digital Analog
Model / REF:
9001903
UPC Codes:
00842092181959
Lot Numbers:
251432
Product: 3i Certain-compatible 6.0mm Digital Analog
Model / REF:
9002003
UPC Codes:
00842092178737
Lot Numbers:
250602
Product: Astra-compatible 3.0mm Digital Analog
Model / REF:
9002103
UPC Codes:
00842092178775
Lot Numbers:
250418
Product: Astra-compatible Aqua 3.5/4.0mm Digital Analog
Model / REF:
9002203
UPC Codes:
00842092178812
Lot Numbers:
250213
Product: Astra-compatible Lilac 4.5/5.0mm Digital Analog
Model / REF:
9002203
UPC Codes:
00842092178812
Lot Numbers:
251459
Product: BioHorizons-compatible 3.0mm Digital Analog
Model / REF:
9005203
UPC Codes:
00842092178898
Lot Numbers:
249071
Product: Legacy-compatible 3.0mm Digital Analog
Model / REF:
9005303
UPC Codes:
00842092178997
Lot Numbers:
250335
Product: BioHorizons-compatible 3.5mm/4.5mm Digital Analog
Model / REF:
9005403
UPC Codes:
00842092178928
Lot Numbers:
250223
Product: Legacy-compatible 3.5mm Digital Analog
Model / REF:
9005503
UPC Codes:
00842092178959
Lot Numbers:
250336
Product: Legacy-compatible 5.7mm Digital Analog
Model / REF:
9008503
UPC Codes:
00842092182130
Lot Numbers:
249510
Product: Astra EV 4.8mm Milled Titanium Abutment
Model / REF:
9006767
Lot Numbers:
250215

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94933
Status: Active
Manufacturer: Preat Corp
Sold By: Dental laboratories; Specialized dental distributors
Manufactured In: United States
Units Affected: 185 devices
Distributed To: Alaska, Arizona, Florida, Georgia, Illinois, Louisiana, Maryland, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.