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Recall Observatory FDA recall evidence

Device product

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

Z-1900-2020

April 01, 2020

Class II

Product summary

Firm
Howmedica Osteonics Corp.
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

    reason.no_named_rule · v1.0.0

    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.