FDAFDA · Food and drugs·Recall number Z-1565-2014
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.
Published May 14, 2014 · Recall initiated: December 23, 2011
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
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
- Lot
- S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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