FDA-Device2020-05-13Class II

Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Howmedica Osteonics Corp.
Hazard

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.

Sold states
US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
Affected count
115
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1900-2020

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