Howmedica Osteonics Corp.: Medical Device Recall in 2020 - (Recall #: Z-1900-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2020.
Data Source: FDA.
Product Description:
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Product Classification:
Class II
Date Initiated: April 1, 2020
Date Posted: May 13, 2020
Recall Number: Z-1900-2020
Event ID: 85400
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.
Status: Terminated
Product Quantity: 115
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
Voluntary or Mandated:
Voluntary: Firm initiated