G3 Opticage Expandable Interbody Fusion Device — Class II medical device recall Z-0941-2017
Terminated recall by Interventional Spine Inc, reported 2017-01-11, distributed nationwide. During implantation, the proximal end of the device could separate if the angle between the device and inserti
| Recall number | Z-0941-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Interventional Spine Inc, Irvine, CA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2017-01-03 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 239 units |
| Lot numbers | 011416-D, 011416-E, 021216-A, 021216-B, 021216-C, 030716-A, 030716-B, 032015-B, 032015-C, 033116-B, 033116-C, 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, 081016-E, 081016-F, 081016-G, 081016-H, 083116-B, 083116-C, 083116-D, 090216-A, 090216-B, 090216-C and 3 more |
| Model numbers | 9101-00, 9101-06, 9180-00, 9180-01, 9180-06, 9180-07, 9180-17 |
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).
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.
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-0941-2017. 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.