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Open, Classified

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.

FDA Recall Z-2687-2024 · Posted 2024-08-19

Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNDP
Date Initiated2024-06-25
Product Quantity185 devices

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.

Firm 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]

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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