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Terminated

Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10

FDA Recall Z-1592-2011 · Posted 2011-03-07

Recalling FirmStraumann Manufacturing Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2010-09-30
Date Terminated2011-09-19
Product Quantity20 systems

Reason for Recall

Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071636CODIAGNOSTIX (R) 5.72Ivs Solutions AG · 2007-08-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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