FDA Device recall Z-1665-2013
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into t…
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into t… by Spinefrontier, citing the outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1665-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-24 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | US |
Product
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
Reason
The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
Identifiers
| code_info | Lot/Serial Numbers: 47175 |
|---|
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-1665-2013%22
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