Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SICAT IMPLANT V2.0

FDA Recall Z-2951-2020 · Posted None

Recalling FirmSICAT GMBH & CO. KG
Recall StatusTerminated
Product CodeLLZ
Date Initiated2020-07-15
Date Terminated2024-01-03
Product Quantity853 units

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192348SICAT Implant V2.0Sicat GmbH & Co. KG · 2019-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑