# FDA recall Z-0846-2024

> **XTANT Medical Holdings, Inc** · Class II · device recall initiated 2023-11-28.

## Product

Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

## Reason for recall

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

## Distribution

US distribution in MI.

## Key facts

- **Recall number:** Z-0846-2024
- **Recalling firm:** XTANT Medical Holdings, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-28
- **Report date:** 2024-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Belgrade, MT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2024

## Citation

> AI Analytics. FDA recall Z-0846-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0846-2024. Source: US FDA. Licensed CC0.

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