Reported Sep 16, 2020 · Terminated

SICAT IMPLANT V2.0

Sicat GmbH & Co. Kg

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SICAT GMBH & CO. KG · Brunnenallee 6 · Bonn · N/A

Is this the product you have?

  • SICAT IMPLANT V2.0
Lot codes and dates
  • V2.0
Amount recalled
853 units

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 3, 2024 · Data as of Sep 19, 4:53 PM UTC

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