Z-2687-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2024
- Initiation Date
- June 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 185 devices
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.
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 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
Code Information
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.