Integrity Implants Inc.: Medical Device Recall in 2022 - (Recall #: Z-0421-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 3, 2022

Date Posted: December 14, 2022

Recall Number: Z-0421-2023

Event ID: 91071

Reason for Recall:

Potential for intraoperative screw head separation at weld location.

Status: Terminated

Product Quantity: 50 screws

Code Information:

Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated