FDA recall Z-0421-2023

Product

LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Used in spinal fixation surgery.

Reason for recall

Potential for intraoperative screw head separation at weld location.

Distribution

US distribution to California, Indiana, New York, Oklahoma, Washington DC

Key facts

Status

Terminated

Initiation date

2022-08-03

Report date

2022-12-14

Termination date

2023-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Beach Gardens, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2023