Recall – Dental implant planning software incorrectly exports implant positions

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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.