FDA recall Z-2951-2020

Product

SICAT IMPLANT V2.0

Reason for recall

A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD.

Distribution

Worldwide distribution

Key facts

Status

Terminated

Initiation date

2020-07-15

Report date

2020-09-16

Termination date

2024-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bonn, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2951-2020