Howmedica Osteonics Corp. recalls Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
- Recall date
- April 1, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1900-2020
- FDA classification
- Class II
- Brand / firm
- Howmedica Osteonics Corp.
- Sold / distributed
- US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
Why it was recalled
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
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