Z-1592-2011

Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and...

Name: Z-1592-2011 Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and...
Creator: Straumann Manufacturing Inc.
Published: 2010-09-30
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2010-09-30 / Terminated / root cause: software

FDA source

Straumann Manufacturing Inc. began a recall of Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10 on 2010-09-30. The reason FDA records is "Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1592-2011
Status: Terminated
Initiated: 2010-09-30
Posted: 2011-03-07
Terminated: 2011-09-19
Recalling firm: Straumann USA, LLC
Product: Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
Root cause tag: software
FDA 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 in commerce: 20 systems
Distribution: Nationwide
Product codes and lots: 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

Product code LLZ

K071636Class IICodiagnostix (R) 5.72Ivs Solutions AG / cleared 2007-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)