FDAFDA · Food and drugs·Recall number 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 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
Published July 10, 2013 · Recall initiated: May 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
- Lot
- Lot/Serial Numbers: 47175
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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