FDA Medical Device Recalls (openFDA)
Straumann Manufacturing Inc.: Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10
- Recall number
- Z-1592-2011
- Recalling firm
- Straumann Manufacturing Inc.
- Product
- Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10
- Status
- Terminated
- Initiated
- 2010-09-30
- Posted
- 2011-03-07
- Terminated
- 2011-09-19
- Reason
- Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
- Root cause
- Software design
- Action
- Straumann notified accounts of this correction by letter dated September 30, 2010 and delivered via Federal Express Delivery Service. The upgrade is available on-line by logging into the coDiagnostiX system and enabling the automatic upgrade to occur.
- Quantity
- 20 systems
- Distribution
- Nationwide
- Lot, serial or model codes
- Article Number Description Version 019.0333 Offline Upgrade CDX Station 7 EN (6+) 7.0.2.10 019.0334 Offline Upgrade CDX PPP 7 EN 7.0.2.10 019.0343 coDiagnostiX Station V 7.0 EN 7.0.2.10 019.0344 coDiagnostiX PPP V 7.0 EN 7.0.2.10 019.0345 coDiagnostiX coDoctor V 7.0 EN 7.0.2.10
- 510(k) numbers
- ["K071636"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
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