FDA Device recall Z-2182-2014
Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewP…
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewP… by Integra Lifesciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2182-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-27 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | TX |
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.
Identifiers
| code_info | The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2182-2014%22
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