SICAT IMPLANT V2 — Class II medical device recall Z-2951-2020
Terminated recall by SICAT GMBH & CO. KG, reported 2020-09-16. A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT
| Recall number | Z-2951-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SICAT GMBH & CO. KG, Bonn, Germany |
| Recall initiated | 2020-07-15 |
| Classified | 2020-09-10 |
| Reported by FDA | 2020-09-16 |
| Terminated | 2024-01-03 |
| Quantity | 853 units |
| Reason classes | software |
Product
SICAT IMPLANT V2.0
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2951-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.