Device product
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Z-1900-2020
Product summary
- Event
- Event 85400
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115
- Official record key
device-enforcement:Z-1900-2020
Official wording
Reason: 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.
Code information: Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979
Distribution pattern: US distribution to California Colorado Florida Georgia Illinois Indiana Kansas Michigan Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
Derived failure modes
-
Unknown
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.