Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the p
FDA device recall Z-3184-2011 · posted 2011-09-13 · Terminated
Recall details
- Recalling firm
- Straumann Manufacturing Inc.
- Reason for recall
- Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
- Action taken
- Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 272
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-08-04
- Date posted
- 2011-09-13
- Date terminated
- 2012-05-23
- 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 |