FDA recall Z-0152-2024

Preat Corp · Class II · device

Product

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Reason for recall

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

Distribution

US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

Key facts

Status
Ongoing
Initiation date
2023-07-18
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2024