Integra LifeSciences Corp.: Medical Device Recall in 2014 - (Recall #: Z-1961-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 9, 2014

Date Posted: July 9, 2014

Recall Number: Z-1961-2014

Event ID: 68498

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.

Status: Terminated

Product Quantity: 94 units

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated