Drug recall
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
FDA recall event 85400 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 85400 |
|---|---|
| Recall numbers | Z-1900-2020 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 1, 2020 |
| Report date | May 13, 2020 |
| Termination date | Aug 27, 2020 |
| City | Allendale |
| State | NJ |
| Country | United States |
| FEI number | 3004024955 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: