# FDA recall Z-1283-2021

> **In2Bones, SAS** · Class II · device recall initiated 2021-02-09.

## Product

In2Bones Shannon Percutaneous Burr - Product Usage:  indicated for forefoot mini-invasive and percutaneous surgery.

## Reason for recall

This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.

## Distribution

US Nationwide distribution in the state of TN.

## Key facts

- **Recall number:** Z-1283-2021
- **Recalling firm:** In2Bones, SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-09
- **Report date:** 2021-03-31
- **Termination date:** 2024-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ecully, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2021

## Citation

> AI Analytics. FDA recall Z-1283-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1283-2021. Source: US FDA. Licensed CC0.

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