Recall Z-0360-2013
NuVasive Inc · initiated January 5, 2009
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Codes / lots: Batch: JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, JK2244
Reason for recall
The tulip portion of the screw assembly can disengage from the shank after implantation.
FDA-determined cause: Device Design
Action taken
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 further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected. Customers with questions or concerns are instructed to contact the firm at (858) 909-1964.
Details
- Recall number
- Z-0360-2013
- Initiated
- January 5, 2009
- Posted by FDA
- November 19, 2012
- Terminated
- November 19, 2012
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 240 units total
- Distribution
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- Recalling firm
- NuVasive Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0348-2013 Class II | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0349-2013 Class II | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0350-2013 Class II | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0351-2013 Class II | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0352-2013 Class II | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0353-2013 Class II | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0354-2013 Class II | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0355-2013 Class II | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0356-2013 Class II | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0357-2013 Class II | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0358-2013 Class II | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0359-2013 Class II | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0361-2013 Class II | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0362-2013 Class II | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0363-2013 Class II | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0364-2013 Class II | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0365-2013 Class II | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0366-2013 Class II | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0367-2013 Class II | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0368-2013 Class II | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0369-2013 Class II | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0370-2013 Class II | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0371-2013 Class II | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0372-2013 Class II | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0373-2013 Class II | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0374-2013 Class II | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0375-2013 Class II | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0376-2013 Class II | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0377-2013 Class II | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0378-2013 Class II | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |