Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LineSider Spinal System pedicle screws Recalled by Integrity Implants Inc. Due to Potential for intraoperative screw head separation at weld...

Date: August 3, 2022
Company: Integrity Implants Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integrity Implants Inc. directly.

Affected Products

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.

Quantity: 50 screws

Why Was This Recalled?

Potential for intraoperative screw head separation at weld location.

Where Was This Sold?

This product was distributed to 1 state: DC

Affected (1 state)Not affected

About Integrity Implants Inc.

Integrity Implants Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report