Z-2951-2020Class II

Sicat Implant V2.0

Name: Z-2951-2020 Sicat Implant V2.0
Creator: Sicat Gmbh & Co. Kg
Published: 2020-07-15
License: https://open.fda.gov/license/

Sicat GmbH & Co. KG / initiated 2020-07-15 / Terminated / root cause: software

FDA source

SICAT GMBH & CO. KG began a recall of SICAT IMPLANT V2.0 on 2020-07-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2951-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-15
Posted: 2020-09-10
Terminated: 2024-01-03
Recalling firm: Sicat GmbH & Co. KG
Product: Sicat Implant V2.0
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: On 07/15/2020 customer notification letter was sent to all users/customers who have the 2.0 version of the software installed in the system. These users are instructed to only use the system for specific cases as defined in the field safety notice. The firm plans on implementing a new software version in July 2020 to correct the issues found.
Quantity in commerce: 853 units
Distribution: Worldwide distribution
Product codes and lots: V2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2951-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2951-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-10

Product code LLZ

K192348Class IISICAT Implant V2.0Sicat GmbH & Co. KG / cleared 2019-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)