—#128439

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.

FDA product code: NKB — Thoracolumbosacral Pedicle Screw System
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083089
Affected lot / code info: The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: US Distribution in TX only.

Timeline

Recall initiated: 2014-06-27
Posted by FDA: 2014-08-11
Terminated: 2014-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.