SICAT GMBH & CO. KG Brunnenallee SICAT IMPLANT V2.0 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SICAT IMPLANT V2.0
Brand
SICAT GMBH & CO. KG Brunnenallee
Lot Codes / Batch Numbers
V2.0
Products Sold
V2.0
SICAT GMBH & CO. KG Brunnenallee is recalling SICAT IMPLANT V2.0 due to A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CM. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026