FDA-Device2014-08-20Class II
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.
Integra LifeSciences Corp.
Hazard
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.
Sold states
US Distribution in TX only.
Affected count
4 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2182-2014Don't want to check this manually?
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