StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indi
FDA device recall Z-2187-2013 · posted 2013-09-11 · Terminated
Recall details
- Recalling firm
- Spine Wave, Inc.
- Reason for recall
- A component Superior endplate manufactured from a different polymer than specified
- Action taken
- Spine Wave notified surgeons verbally on 5/14/13 and followed by written notification on June 6, 2013 of the incorrect polymer used for the endplate and the health risks.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 17 units
- Distribution
- Distributed in the states of FL and OR.
- Date initiated
- 2013-05-14
- Date posted
- 2013-09-11
- Date terminated
- 2014-02-10
- Location
- Shelton, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAXX(R) IB SYSTEM (K123461) | Spine Wave, Inc. | 2013-04-11 |