# FDA recall Z-1046-2019

> **Avitus Orthopaedics, Inc.** · Class II · device recall initiated 2019-02-18.

## Product

Avitus¿ Bone Harvester w/ Filter Insert - 8mm   intended to harvest cancellous bone and bone marrow  Catalog Number: BH-110     The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow

## Reason for recall

Breach in the sterile barrier pouch may compromise sterility of the device.

## Distribution

US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.

## Key facts

- **Recall number:** Z-1046-2019
- **Recalling firm:** Avitus Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-18
- **Report date:** 2019-04-03
- **Termination date:** 2020-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Farmington, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1046-2019

## Citation

> AI Analytics. FDA recall Z-1046-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1046-2019. Source: US FDA. Licensed CC0.

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