CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report

S-lift Inserter Outer Sleeve recalled by SpineFrontier

SpineFrontier is recalling S-lift Inserter Outer Sleeve, distributed nationwide in the US. The recall was initiated on 24 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Serial Numbers: 47175

Quantity recalled12 devices

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-1665-2013
FDA event ID: 65429
Recalling firm: SpineFrontier, Beverly, MA
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2013
FDA classified: 4 Jul 2013
Reported: 10 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

24 May 2013	Recall initiated by company
4 Jul 2013	Classified by FDA	+41 days
10 Jul 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA

Nationwide Florida Massachusetts Missouri New Jersey Oklahoma Texas

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot/Serial Numbers: 47175

Where was it sold?

USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA

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

All 33

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24 Jul 2019Device	CLASS II	A-cift SoloFuse Fixed Angle Driver recalled by SpineFrontier	SpineFrontier	Other	4 states
29 Apr 2015Device	CLASS II	MISquito Percutaneous Pedicle Screw System Surgical Technique recalled	SpineFrontier	Device Malfunction	Nationwide
21 Jan 2015Device	CLASS II	lnline Persuader- PedFuse Pedicle Screw System recalled by SpineFrontier	SpineFrontier	Device Malfunction	Nationwide
14 May 2014Device	CLASS II	S-Lift Lock Shaft Inserter, an instrument used recalled by SpineFrontier	SpineFrontier	Sterility	Nationwide
22 Jan 2014Device	CLASS II	Arena-L 38x28Trial Head I 10¿ Lordotic recalled by SpineFrontier	SpineFrontier	Device Malfunction	VA

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