# FDA recall Z-1319-2024

> **In2Bones, SAS** · Class II · device recall initiated 2024-01-26.

## Product

I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

## Reason for recall

This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm.  The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

## Distribution

US Nationwide distribution in the state of Tennessee.

## Key facts

- **Recall number:** Z-1319-2024
- **Recalling firm:** In2Bones, SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-26
- **Report date:** 2024-03-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1319-2024

## Citation

> AI Analytics. FDA recall Z-1319-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1319-2024. Source: US FDA. Licensed CC0.

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