# FDA recall Z-0418-2023

> **Integrity Implants Inc.** · Class II · device recall initiated 2022-01-27.

## Product

LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated.  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.  Labeled as the following sizes:      a. 5.5mm x 35mm;      b. 5.5mm x 40mm;      c. 5.5mm x 45mm;      d. 5.5mm x 50mm;      e. 5.5mm x 55mm;      f. 6.5mm x 35mm;      g. 6.5mm x 40mm;      h. 6.5mm x 45mm;      i. 6.5mm x 50mm;      j. 6.5mm x 55mm;      k. 6.5mm x 60mm;      l. 7.5mm x 35mm;      m. 7.5mm x 40mm;      n. 7.5mm x 50mm;      o. 7.5mm x 55mm;      p. 7.5mm x 60mm;      q. 8.5mm x 35mm;      r. 8.5mm x 40mm;      s. 8.5mm x 45mm;      t. 8.5mm x 50mm;      u.8.5mm x 55mm;       v. 8.5mm x 60mm;      Used in spinal fixation surgery.

## Reason for recall

Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.

## Distribution

Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.

## Key facts

- **Recall number:** Z-0418-2023
- **Recalling firm:** Integrity Implants Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-27
- **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-0418-2023

## Citation

> AI Analytics. FDA recall Z-0418-2023. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0418-2023. Source: US FDA. Licensed CC0.

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