FDA recall Z-0019-2020

Paltop Advanced Dental Solutions Ltd · Class II · device

Product

Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

Reason for recall

Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.

Distribution

AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA

Key facts

Status: Terminated
Initiation date: 2019-05-30
Report date: 2019-10-09
Termination date: 2020-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Caesarea, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0019-2020