Recall Z-0941-2017 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Interventional Spine Inc
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 hav
| Date | Jan 3, 2017 (initiated Nov 22, 2016) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 239 units |
| Distribution | Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA. |
| FDA record | Open on fda.gov |