ModerateClass IITerminated

FDA Devices recall · Reported January 11, 2017

G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbod

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 11, 2017. Severity: Moderate. Recall number: Z-0941-2017.

Q: Where was the recalled product distributed?

Distribution: Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA..

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.

During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device …

Recall #: Z-0941-2017
Affected scope: 239 units
Initiated: November 22, 2016

Compiled from official public sources by the publisher. · Updated September 2026

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Interventional Spine Inc recalled G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180… - a moderate-severity action.

G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180… was recalled by Interventional Spine Inc in January 11, 2017. Reason: During implantation, the proximal end of the device could separate if the angle between the device and insert…. Check the official notice for the remedy. Verify recall #Z-0941-2017 with the FDA Devices before acting.

The recall

Interventional Spine Inc issued this moderate-severity FDA Devices recall-During implantation, the proximal end of the device could separate if the angle between the device and insert….

Moderate
severity level: 239 units
affected scope: Class II
classification: January 11, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0941-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

Reason for recall

During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.

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-0941-2017
Date reported	January 11, 2017
Date initiated	November 22, 2016
Recalling firm	Interventional Spine Inc
Firm location	Irvine, CA
Affected scope	239 units
Distribution	Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA.

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

Scale of Impact

239 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-0941-2017) 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? ▼

During implantation, the proximal end of the device could separate if the angle between the device and insertion instrument is too steep. This separation will prevent the device from expanding.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 11, 2017. Severity: Moderate. Recall number: Z-0941-2017.

Where was the recalled product distributed? ▼

Distribution: Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA..

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.

Nationwide recalls with similar severity or category timing

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This recall: FDA Devices, reported January 11, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026