# FDA recall Z-1900-2020

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2020-04-01.

## Product

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

## 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.

## Distribution

US distribution to California  Colorado  Florida  Georgia  Illinois  Indiana  Kansas  Michigan  Ohio  Pennsylvania  Texas  Utah  Virginia  Washington  Wisconsin

## Key facts

- **Recall number:** Z-1900-2020
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-01
- **Report date:** 2020-05-13
- **Termination date:** 2020-08-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allendale, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1900-2020

## Citation

> AI Analytics. FDA recall Z-1900-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1900-2020. Source: US FDA. Licensed CC0.

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