Preat Corp: 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-

Hazard

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.

Details from the source

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. 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 Quantity: 185 devices Lot/code info: 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.

UPC codes

00842092178690, 00842092181898, 00842092181959, 00842092178737, 00842092178775, 00842092178812, 00842092178898, 00842092178997, 00842092178928, 00842092178959, 00842092182130

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.