# FDA recall Z-0421-2023

> **Integrity Implants Inc.** · Class II · device recall initiated 2022-08-03.

## 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 for recall

Potential for intraoperative screw head separation at weld location.

## Distribution

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

## Key facts

- **Recall number:** Z-0421-2023
- **Recalling firm:** Integrity Implants Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-08-03
- **Report date:** 2022-12-14
- **Termination date:** 2023-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palm Beach Gardens, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2023

## Citation

> AI Analytics. FDA recall Z-0421-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0421-2023. Source: US FDA. Licensed CC0.

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