Home / Recalls / Integrity Implants Inc. / Z-0421-2023

Z-0421-2023 Class II Terminated

Recalled by Integrity Implants Inc. — Palm Beach Gardens, FL

Recall Details

Product Type
Devices
Report Date
December 14, 2022
Initiation Date
August 3, 2022
Termination Date
October 23, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 screws

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.

Reason for Recall

Potential for intraoperative screw head separation at weld location.

Distribution Pattern

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

Code Information

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

Other recalls by Integrity Implants Inc.

  • Z-1008-2025 Class II — Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-001 (December 20, 2024)
  • Z-0418-2023 Class II — LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannu (January 27, 2022)
  • Z-0419-2023 Class II — LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulate (January 27, 2022)
  • Z-0420-2023 Class II — LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. T (January 27, 2022)
  • Z-0405-2019 Class II — FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Ins (February 27, 2018)