S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an… — Class II medical device recall Z-1665-2013
Terminated recall by SpineFrontier, Inc., reported 2013-07-10, distributed nationwide. The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve han
| Recall number | Z-1665-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-05-24 |
| Classified | 2013-07-04 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 12 devices |
| Serial numbers | 47175 |
| Model numbers | SI50003 |
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 for recall
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.
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-1665-2013. 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.