Recall Z-2687-2024— Preat Corp

Class II FDA medical device recall by Preat Corp, initiated 2024-06-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Preat Corp

Classification

Class II

Status

Ongoing

Initiated

2024-06-25

Firm location

Santa Maria, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.