Interventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices
Interventional Spine Inc is recalling 239 G3 Opticage Expandable Interbody Fusion Devices because the proximal end may separate during implantation, preventing the device from expanding.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a medical device that could prevent proper function during surgery, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Interventional Spine Inc is recalling 239 units of the G3 Opticage Expandable Interbody Fusion Device, including models 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, and 9101-06. The device is a posterior lumbar intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease.
The recall was initiated because the proximal end of the device could separate if the angle between the device and the insertion instrument is too steep during implantation. This separation prevents the device from expanding as intended. The affected units were distributed nationwide to New York, North Carolina, South Carolina, Pennsylvania, Texas, Ohio, Georgia, New Jersey, Delaware, Arizona, the District of Columbia, California, and Virginia.
Healthcare providers and patients should contact Interventional Spine Inc for further instructions regarding the recall. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- 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
- Manufacturer
- Interventional Spine Inc
- Affected units
- 239
Distribution
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