FDA recall Z-1046-2019

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

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

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