Z-0941-2017Class II

G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17...

Name: Z-0941-2017 G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17...
Creator: Interventional Spine Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Interventional Spine, Inc. / initiated 2016-11-22 / Terminated / root cause: design

FDA source

Interventional Spine Inc began a recall of 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... on 2016-11-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0941-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2017-01-03
Terminated: 2017-02-07
Recalling firm: Interventional Spine, Inc.
Product: 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).
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: design
FDA root cause: Device Design
Action: Interventional Spince, Inc. sent an An Urgent Medical Device Recall letter dated November 22, 2016, to all affected customers to inform them that 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. The letter informs the customers of the risk to health and actions to be taken by the customer/user. Customers were instructed to discontinue use and return device per the enclosed instructions. Complete the enclosed acknowledgment letter and fax, email or mail it to Interventional Spine. Customers with questions were instructed to call Monday through Friday 8am to 5pm (Pacific Time), 949-472-0006 or email [email protected].
Quantity in commerce: 239 units
Distribution: Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA.
Product codes and lots: Lot no. 011416-D 021216-A 021216-B 032015-B 032015-C 033116-B 040915-B 040915-E 041416-A 060116-A 060116-B 060116-C 061616-B 061915-A 061915-B 070714-D 071116-A 071116-B 071116-C 071516-A 071516-B 071916-A 081016-A 081016-B 081016-C 083116-B 083116-B 091516-A 112515-A 033116-C 030716-A 081016-E 090216-C 090216-C 090216-D 030716-B 011416-E 021216-C 081016-F 081016-G 090216-A 090216-A 090216-B 081016-H 083116-C 083116-C 083116-D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0941-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0941-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2017-01-03

Product code MAX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)