Recall Z-1961-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
Integra LifeSciences Corp.
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
| Date | Jul 1, 2014 (initiated Jun 9, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 94 units |
| Distribution | Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083089 | NEWPORT SPINAL SYSTEM Seaspine, Inc., Jan 13, 2009 |