CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
Integra NewPort MIS System recalled by Integra LifeSciences
Integra LifeSciences is recalling Integra NewPort MIS System, distributed in Texas. The recall was initiated on 27 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2182-2014
- FDA event ID
- 68679
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2014
- FDA classified
- 11 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 27 Jun 2014 | Recall initiated by company | |
| 11 Aug 2014 | Classified by FDA | +45 days |
| 20 Aug 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution in TX only.
Questions about this recall
Is Integra NewPort MIS System recalled?
Yes. Integra LifeSciences recalled Integra NewPort MIS System on 27 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2182-2014.
Why was it recalled?
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.
Which lots are affected?
The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)
Where was it sold?
US Distribution in TX only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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