Z-2182-2014Class II

Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort...

Name: Z-2182-2014 Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort...
Creator: Integra LifeSciences Corp.
Published: 2014-06-27
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-06-27 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is... on 2014-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2182-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-27
Posted: 2014-08-11
Terminated: 2014-09-16
Recalling firm: Integra LifeSciences Corporation
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
FDA root cause: Under Investigation by firm
Action: The firm, Integra, sent an "URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE" dated June 27, to its customers. The letter informs the customers that Integra Lifesciences is recalling the Integra NewPort MIS System because there is a possibility that the components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in the surgery. The letter also informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached response form and return it by email or fax as indicated on the form. Customers with questions regarding the recall letter instructions are instructed to contact the Marketing Manager at (760) 207-7050.
Quantity in commerce: 4 units
Distribution: US Distribution in TX only.
Product codes and lots: The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2182-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2182-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-11

Product code NKB

K083089Class IINewport Spinal SystemSeaspine, Inc. / cleared 2009-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)