StaXx¿ IB Convex Expandable Implant — Class II medical device recall Z-2187-2013
Terminated recall by Spine Wave, Inc., reported 2013-09-18, distributed in FL, OR. A component Superior endplate manufactured from a different polymer than specified
| Recall number | Z-2187-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spine Wave, Inc., Shelton, CT, United States |
| Recall initiated | 2013-05-14 |
| Classified | 2013-09-11 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2014-02-10 |
| Distributed | FL, OR |
| Quantity | 17 units |
| Lot numbers | 272L08, 272L09 |
| Model numbers | 1902 |
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 for recall
A component Superior endplate manufactured from a different polymer than specified
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2187-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.