Device product
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.
Z-2182-2014
Product summary
- Event
- Event 68679
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2182-2014
Official wording
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.
Code information: The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)
Distribution pattern: US Distribution in TX only.
Derived failure modes
-
Unknown
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.