# FDA recall Z-0597-2018

> **OrthoPediatrics Corp** · Class II · device recall initiated 2017-08-03.

## Product

Response 5.5/6.0 Spine System   7.0mm x 40mm  Pedicle Screw    Product Usage:  Posterior non-cervical pedicle screw fixation

## Reason for recall

The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0597-2018
- **Recalling firm:** OrthoPediatrics Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-03
- **Report date:** 2018-02-21
- **Termination date:** 2019-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2018

## Citation

> AI Analytics. FDA recall Z-0597-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0597-2018. Source: US FDA. Licensed CC0.

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