Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10
FDA device recall Z-1592-2011 · posted 2011-03-07 · Terminated
Recall details
- Recalling firm
- Straumann Manufacturing Inc.
- Reason for recall
- Software: Surgical Error may occur when the implant length is changed after positioning the surgical sleeve.
- Action taken
- 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
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 20 systems
- Distribution
- Nationwide
- Date initiated
- 2010-09-30
- Date posted
- 2011-03-07
- Date terminated
- 2011-09-19
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODIAGNOSTIX (R) 5.72 (K071636) | Ivs Solutions AG | 2007-08-09 |