SpineFrontier S-Lift Lock Shaft Inserter — Class II medical device recall Z-1565-2014
Terminated recall by SpineFrontier, Inc., reported 2014-05-14, distributed nationwide. It has been verified through field use that there are two possible breakages that may occur when using SI50001
| Recall number | Z-1565-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2011-12-23 |
| Classified | 2014-05-07 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 30 devices |
| Reason classes | sterility |
| Lot numbers | 2478901R, 42613, 42615, 7625701 |
| Model numbers | SI50001 |
Product
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Reason for recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
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-1565-2014. 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.