Home / Recalls / Medical Devices
Integrity Implants Inc. recalls LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N
Recalled December 14, 2022 · FDA recall Z-0421-2023 · Integrity Implants
Hazard
Potential for intraoperative screw head separation at weld location. · FDA Class II
Units
50 screws
Sold at
US distribution to California, Indiana, New York, Oklahoma, Washington DC
Description
Potential for intraoperative screw head separation at weld location.
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.
Manufacturer(s)
Integrity Implants Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →