Z-1961-2014Class II

MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm)...

Name: Z-1961-2014 MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm)...
Creator: Integra LifeSciences Corp.
Published: 2014-06-09
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2014-06-09 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2014-06-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1961-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Posted: 2014-07-01
Terminated: 2014-11-06
Recalling firm: Integra LifeSciences Corporation
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
Product code: NKB Thoracolumbosacral Pedicle Screw System
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 root cause: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1961-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1961-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-01

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)