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