# FDA recall Z-0721-2022

> **Orthosoft, Inc. dba Zimmer CAS** · Class II · device recall initiated 2022-01-07.

## Product

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

## Reason for recall

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.

## Key facts

- **Recall number:** Z-0721-2022
- **Recalling firm:** Orthosoft, Inc. dba Zimmer CAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-07
- **Report date:** 2022-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montreal, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2022

## Citation

> AI Analytics. FDA recall Z-0721-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0721-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*