Preat Implant Prosthetics recallZ-2687-2024 · Preat Corp · initiated Jun 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Preat Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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]
Recall details
- Recall number
- Z-2687-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 25, 2024
- Posted by the FDA
- Aug 19, 2024
- Recalling firm
- Preat Corp
- Quantity
- 185 devices
- Product code
- NDP
- 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 description
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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
11 devices in the FDA device registry whose identifier appears in the recall's code information.
- Preat Implant Prosthetics 9000703Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9002003Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9002103Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9002203Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9005203Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9005403Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9005503Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Preat Implant Prosthetics 9005303Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Straumann® TL WN-compatible 9001303Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- 3i Certain®-compatible 9001903Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
- Legacy-compatible 9008503Preat Corporation · Accessories, Implant, Dental, Endosseous1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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