MIS Rod 2 — Class II medical device recall Z-1961-2014
Terminated recall by Integra LifeSciences Corp., reported 2014-07-09, distributed in CA, FL, IL, MD, MO, TN, TX. Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from spe
| Recall number | Z-1961-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2014-06-09 |
| Classified | 2014-07-01 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2014-11-06 |
| Distributed | CA, FL, IL, MD, MO, TN, TX |
| Countries outside the US | AU, CZ, ES |
| Quantity | 94 units |
| Lot numbers | Z21781A |
| Model numbers | 60-0545 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1961-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.