G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06
FDA device recall Z-0941-2017 · posted 2017-01-03 · Terminated
Recall details
- Recalling firm
- Interventional Spine Inc
- 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.
- Action taken
- 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 cs@i-spineinc.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 239 units
- Distribution
- Nationwide Distribution to NY, NC, SC, PA, TX, OH, GA, NJ, DE, AZ, DC, CA, and VA.
- Date initiated
- 2016-11-22
- Date posted
- 2017-01-03
- Date terminated
- 2017-02-07
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Opticage(R) Expandable Interbody Fusion Device (K160464) | Interventional Spine, Inc. | 2016-04-04 |
| Opticage Expandable Interbody Fusion Device (K152156) | Interventional Spine, Inc. | 2015-10-19 |