Medical device recalls Moderate risk

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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