Recall Z-2951-2020— SICAT GMBH & CO. KG

Name: FDA recall Z-2951-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-15

Class II · Terminated

Class II FDA medical device recall by SICAT GMBH & CO. KG, initiated 2020-07-15, terminated 2024-01-03. It names one FDA 510(k) clearance: K192348. Product: SICAT IMPLANT V2.0. 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: SICAT GMBH & CO. KG
Classification: Class II
Status: Terminated
Initiated: 2020-07-15
Terminated: 2024-01-03
Firm location: Bonn, Germany

510(k) clearances named in this recall

1 on FDA's record

K192348 — SICAT Implant V2.0Sicat GmbH & Co. KG·cleared 2019-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.