Montreal, Canada
Orthosoft, Inc. dba Zimmer CAS recalls
1 recall recorded since 2018, most recently on 7 January 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 January 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0721-2022
- NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.