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U.S. Department of Health and Human Services

Class 2 Device Recall Integra NewPort MIS System

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 Class 2 Device Recall Integra NewPort MIS Systemsee related information
Date Initiated by FirmJune 27, 2014
Date PostedAugust 11, 2014
Recall Status1 Terminated 3 on September 16, 2014
Recall NumberZ-2182-2014
Recall Event ID 68679
510(K)NumberK083089 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc - Product Code NKB
ProductIntegra 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.
Code Information The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)  
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactMr. David E. Gronostajski
609-936-6822
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce4 units
DistributionUS Distribution in TX only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NKB
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