# FDA recall Z-1374-2021

> **Arrow International Inc** · Class II · device recall initiated 2021-03-08.

## Product

Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)  Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.

## Reason for recall

Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1374-2021
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-08
- **Report date:** 2021-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2021

## Citation

> AI Analytics. FDA recall Z-1374-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1374-2021. Source: US FDA. Licensed CC0.

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