FDA Enforcement
Class II
Terminated
SICAT IMPLANT V2.0
Recall: Z-2951-2020
·
Reported September 16, 2020
Enforcement
- Recall Number
- Z-2951-2020
- Event ID
- 86165
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- SICAT GMBH & CO. KG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 16, 2020
- Initiation Date
- July 15, 2020
- Classification Date
- September 10, 2020
- Termination Date
- January 3, 2024
- Address
- Brunnenallee 6, Bonn, N/A, Germany
Description
SICAT IMPLANT V2.0
Reason
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.
Code Info
V2.0
Distribution
Worldwide distribution
Quantity
853 units