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