# FDA recall Z-3000-2017

> **Valorem Surgical LLC** · Class II · device recall initiated 2017-06-21.

## Product

PALLAS M/MAXIMIS Rod Checker and T-Bar. Part of MAXIMIS Pedicle Screw Spinal Fixation System.  Valorem Surgical, Chicago, IL.  Product labeled as Pallas M Spinal Fixation System through 2015.  Intended for posterior pedicle screw fixation of the non-cervical spine.

## Reason for recall

Devices are not consistent with Quality System Requirements.

## Distribution

Nationwide Distribution - US including CA and VA.

## Key facts

- **Recall number:** Z-3000-2017
- **Recalling firm:** Valorem Surgical LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-21
- **Report date:** 2017-08-16
- **Termination date:** 2018-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3000-2017

## Citation

> AI Analytics. FDA recall Z-3000-2017. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-3000-2017. Source: US FDA. Licensed CC0.

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