Medical device recalls Moderate risk

Avitus Orthopaedics, Inc. recalls Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-21…

Recall date
February 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1047-2019
FDA classification
Class II
Brand / firm
Avitus Orthopaedics, Inc.
Sold / distributed
US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow

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