Class II — Spine Wave, Inc.
| Recalling firm | SPINE WAVE, INC. |
|---|---|
| Registered facility | SPINE WAVE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A component Superior endplate manufactured from a different polymer than specified |
| 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. |
| Quantity | 17 units |
| Distribution | Distributed in the states of FL and OR. |
| Initiated | 2013-05-14 |
| Classified | 2013-09-11 |
| Terminated | 2014-02-10 |
| Recall number | Z-2187-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spine Wave, Inc. (Z-2187-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65968/
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