CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report
S-Lift Lock Shaft Inserter, an instrument used recalled by SpineFrontier
SpineFrontier is recalling S-Lift Lock Shaft Inserter, an instrument used with S-lift Intervertebral Body Fusion, distributed nationwide in the US. The recall was initiated on 23 Dec 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1565-2014
- FDA event ID
- 63145
- Recalling firm
- SpineFrontier, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2011
- FDA classified
- 7 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 23 Dec 2011 | Recall initiated by company | |
| 7 May 2014 | Classified by FDA | +866 days |
| 14 May 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Nationwide ColoradoFloridaIllinoisMassachusettsMissouriOklahomaTexas
Questions about this recall
Why was it recalled?
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
Which lots are affected?
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
Where was it sold?
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SpineFrontier
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|---|---|---|---|---|---|
| Device | CLASS II | A-cift SoloFuse Fixed Angle Driver recalled by SpineFrontier | SpineFrontier | Other | 4 states |
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| Device | CLASS II | lnline Persuader- PedFuse Pedicle Screw System recalled by SpineFrontier | SpineFrontier | Device Malfunction | Nationwide |
| Device | CLASS II | Arena-L 38x28Trial Head I 10¿ Lordotic recalled by SpineFrontier | SpineFrontier | Device Malfunction | VA |
| Device | CLASS II | Arena-L Trial Handle recalled by SpineFrontier | SpineFrontier | Device Malfunction | VA |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |