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.
This recall has been terminated (originally issued May 7, 2014).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- December 23, 2011
- Posted
- May 7, 2014
- Terminated
- May 20, 2014
- Recall Number
- Z-1565-2014
- Quantity
- 30 devices
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Lot / Code Info
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
Root Cause
Device Design
Action Taken
Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717