FDA Device recall Z-2187-2013
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar by Spine Wave, citing A component Superior endplate manufactured from a different polymer than specified.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2187-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-14 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spine Wave |
| Distribution | FL, OR |
Product
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Reason
A component Superior endplate manufactured from a different polymer than specified
Identifiers
| code_info | Lot Numbers: 272L08 and 272L09 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2187-2013%22
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