Z-1900-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 1, 2020
- Termination Date
- August 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 115
Product Description
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 Pattern
US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
Code Information
Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979