Recall Z-0377-2013 ยท NKB Thoracolumbosacral Pedicle Screw System
NuVasive Inc
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
| Date | Nov 19, 2012 (initiated Jan 5, 2009) |
| Status | Terminated |
| Reason | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Root cause | Device Design |
| Action | Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any f |
| Quantity | 240 units total |
| Distribution | Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082332 | NUVASIVE SPHERX SYSTEM Nuvasive, Inc., Oct 10, 2008 |