FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: 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.
- Recall number
- Z-1565-2014
- Recalling firm
- SpineFrontier, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-12-23
- Posted
- 2014-05-07
- Terminated
- 2014-05-20
- Reason
- 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
- Root cause
- Device Design
- Action
- 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
- Quantity
- 30 devices
- Distribution
- US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
- Lot, serial or model codes
- S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
- 510(k) numbers
- ["K092815"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3005977257
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28