VisuALIF — Class II medical device recall Z-2258-2013
Terminated recall by Spine Smith Holdings, LLC, reported 2013-09-25, distributed in FL. The product has the potential to be laser marked as a Medium when it actually is a Small.
| Recall number | Z-2258-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spine Smith Holdings, LLC, Austin, TX, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-09-19 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-03-18 |
| Distributed | FL |
| Quantity | 32 |
| Lot numbers | 53AR |
| Model numbers | 0301-1410 |
Product
VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
Reason for recall
The product has the potential to be laser marked as a Medium when it actually is a Small.
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-2258-2013. 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.