Recall Z-2182-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
Integra LifeSciences Corp.
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
| Date | Aug 11, 2014 (initiated Jun 27, 2014) |
| Status | Terminated |
| Reason | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery. |
| Root cause | Under Investigation by firm |
| Action | The firm, Integra, sent an "URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE" dated June 27, to its customers. The letter informs the customers that Integra Lifesciences is recalling the Integra NewPort MIS System because there is a possibility that the components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in the surgery. The letter also informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached response form and return it by email or fax as indicated on the |
| Quantity | 4 units |
| Distribution | US Distribution in TX only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083089 | NEWPORT SPINAL SYSTEM Seaspine, Inc., Jan 13, 2009 |