Recall Z-2182-2014— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2014-06-27, terminated 2014-09-16. It names one FDA 510(k) clearance: K083089. 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.. 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..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-27
- Terminated
- 2014-09-16
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.