Company: SICAT GMBH & CO. KG
Date of Enforcement Report: 9/16/2020
Class II

PRODUCT

SICAT IMPLANT V2.0

Recall Number: Z-2951-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

SICAT GMBH & CO. KG on 7/15/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

853 units

DISTRIBUTION

U.S. Nationwide and International