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U.S. Department of Health and Human Services

Class 2 Device Recall NewPort Spinal System

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  Class 2 Device Recall NewPort Spinal System see related information
Date Initiated by Firm June 09, 2014
Date Posting Updated July 01, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-1961-2014
Recall Event ID 68498
510(K)Number K083089  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product MIS Rod 2, a component of the NewPort System.
Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm).
The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
Code Information Lot No.

Z21781A (45mm NewPort MIS Rod, 2), Z21956A (50mm NewPort MIS Rod, 2), Z21782A (55mm NewPort MIS Rod, 2), Z21957A (60mm NewPort MIS Rod, 2), Z21784A (75mm NewPort MIS Rod, 2), Z21958A (80mm NewPort MIS Rod, 2).
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Mr. David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall
Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.
FDA Determined
Cause 2
Under Investigation by firm
Action A customer notification letter was sent on 6/9/14 to their customers and distributors who purchased the Integra NewPort System MIS Rod, 2 to inform them there may be a potential that the hex on some NewPort System MIS Rod, 2 are up to 30 degrees offset from specification requirements causing misalignment with the inserter. Customers are instructed to complete and return the customer response form and return by email or fax as indicated on the form. Customers with questions are instructed to contact Customer Service at (866) 942-8698.
Quantity in Commerce 94 units
Distribution Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NKB and Original Applicant = SEASPINE, INC.
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