Avitus Orthopaedics, Inc. recalls Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-11…
- Recall date
- February 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1046-2019
- 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 - 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
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