FDA recall Z-1900-2020

Product

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

Reason for recall

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.

Distribution

US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin

Key facts

Status

Terminated

Initiation date

2020-04-01

Report date

2020-05-13

Termination date

2020-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allendale, NJ, United States

Primary source

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