CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 I
FDA device recall Z-1468-2014 · posted 2014-04-17 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
- Action taken
- Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 9,445 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-12-13
- Date posted
- 2014-04-17
- Date terminated
- 2016-04-21
- Location
- Raynham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM (K113526) | Medos International SARL | 2012-02-16 |
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM (K112156) | Medos International SARL | 2011-10-17 |