FDA Device recall Z-0421-2023
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated
- FDA Device
- Class II
- terminated
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated by Integrity Implants, citing potential for intraoperative screw head separation at weld location.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0421-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-03 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Integrity Implants |
| Distribution | CA, DC, IN, NY, OK, WA |
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
Potential for intraoperative screw head separation at weld location.
Identifiers
| code_info | Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0421-2023%22
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