ModerateClass IITerminated

FDA Devices recall · Reported July 9, 2014

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1961-2014.

Q: Where was the recalled product distributed?

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

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1961-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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…

Recall #: Z-1961-2014
Affected scope: 94 units
Initiated: June 9, 2014

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

View my saved recalls

Integra LifeSciences Corp. recalled MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm)… - a moderate-severity action.

MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm)… was recalled by Integra LifeSciences Corp. in July 9, 2014. Reason: Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from sp…. Check the official notice for the remedy. Verify recall #Z-1961-2014 with the FDA Devices before acting.

Share: Post Facebook LinkedIn WhatsApp Email

The recall

Integra LifeSciences Corp. issued this moderate-severity FDA Devices recall-Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from sp….

Moderate
severity level: 94 units
affected scope: Class II
classification: July 9, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1961-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1961-2014) was formally reported on July 9, 2014, with the manufacturer initiating the action on June 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra LifeSciences Corp. is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records list the affected scope as 94 units.

The documented reason for this recall is: 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 lordosi… Distribution data in the federal record shows the product reached: Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

94 units

Related Recalls

3 from same agency

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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1961-2014
Date reported	July 9, 2014
Date initiated	June 9, 2014
Recalling firm	Integra LifeSciences Corp.
Firm location	Plainsboro, NJ
Affected scope	94 units
Distribution	Worldwide Distribution. US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

94 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1961-2014) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 9, 2014. Severity: Moderate. Recall number: Z-1961-2014.

Where was the recalled product distributed? ▼

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

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1961-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

CPSC Moderate

Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards

· 2026-07-02

CPSC Moderate

Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…

· 2026-06-25

CPSC Moderate

Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…

· 2026-06-18

FDA Devices Moderate

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…

GE Medical Systems Information Technologies Inc · 2026-06-03

FDA Devices Critical

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…

Medline Industries, LP · 2026-06-03

Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →

Browse all Medical Devices recalls →

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 9, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.