FDA Device recall Z-1961-2014
MIS Rod 2, a component of the NewPort System
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of MIS Rod 2, a component of the NewPort System by Integra Lifesciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1961-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-09 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | CA, FL, IL, MD, MO, TN, TX |
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
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.
Identifiers
| code_info | Lot No. Z21781A (45mm NewPort MIS Rod, 2) Z21956A (50mm NewPort MIS Rod, 2) Z21782A (55mm NewPort MIS Rod, 2) Z21…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1961-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.