FDA Device recall Z-2258-2013
VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number…
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number… by Spine Smith Holdings, citing the product has the potential to be laser marked as a Medium when it actually is a Small.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2258-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-31 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spine Smith Holdings |
| Distribution | FL |
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
The product has the potential to be laser marked as a Medium when it actually is a Small.
Identifiers
| code_info | Part Number: 0301-1410, Lot 53AR |
|---|
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-2258-2013%22
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