FDA Medical Device Recalls (openFDA)
SICAT GMBH & CO. KG: SICAT IMPLANT V2.0
- Recall number
- Z-2951-2020
- Recalling firm
- SICAT GMBH & CO. KG
- Product
- SICAT IMPLANT V2.0
- Status
- Terminated
- Initiated
- 2020-07-15
- Posted
- not on file
- Terminated
- 2024-01-03
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 853 units
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- V2.0
- 510(k) numbers
- ["K192348"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006098230
- Firm city
- Bonn
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28