FDA Device recall Z-1900-2020
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 by Howmedica Osteonics, citing shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potenti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1900-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-01 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Howmedica Osteonics |
| Distribution | CA, CO, FL, GA, IL, IN, KS, MI, OH, PA, TX, UT, VA, WA, WI |
Product
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
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.
Identifiers
| code_info | Specific shipments of 2101-0005: Lots A1907006, A1908003; 2101-0010: Lots A1903054, A1906006. UDI 00808232000962, 00808232000979 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1900-2020%22
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