—#128087

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

FDA product code: NKB — Thoracolumbosacral Pedicle Screw System
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083089
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.

Timeline

Recall initiated: 2014-06-09
Posted by FDA: 2014-07-01
Terminated: 2014-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128087. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.