CLASS II Device recall · Reported 16 Sep 2020 · FDA Enforcement Report
Sicat Implant V2.0 recalled by Sicat Gmbh & Co. Kg
Sicat Gmbh & Co. Kg is recalling Sicat Implant V2.0. The recall was initiated on 15 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2951-2020
- FDA event ID
- 86165
- Recalling firm
- Sicat Gmbh & Co. Kg, Bonn
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2020
- FDA classified
- 10 Sep 2020
- Reported
- 16 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Jul 2020 | Recall initiated by company | |
| 10 Sep 2020 | Classified by FDA | +57 days |
| 16 Sep 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
SICAT IMPLANT V2.0
Where it was distributed
Worldwide distribution
Questions about this recall
Is Sicat Implant V2.0 recalled?
Yes. Sicat Gmbh & Co. Kg recalled Sicat Implant V2.0 on 15 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2951-2020.
Why was it 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.
Which lots are affected?
V2.0
Where was it sold?
Worldwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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