# FDA recall Z-1797-2021

> **Medtronic Sofamor Danek USA, Inc** · Class II · device recall initiated 2021-04-27.

## Product

Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.

## Reason for recall

Product is impacted by a thread profile defect due to a manufacturing issue.

## Distribution

International distribution in the countries of France, Switzerland and Jordan. No US distribution.

## Key facts

- **Recall number:** Z-1797-2021
- **Recalling firm:** Medtronic Sofamor Danek USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-27
- **Report date:** 2021-06-16
- **Termination date:** 2024-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2021

## Citation

> AI Analytics. FDA recall Z-1797-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1797-2021. Source: US FDA. Licensed CC0.

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