Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NavitrackER Kit A: Knee Recalled by Orthosoft, Inc. dba Zimmer CAS Due to The product was released for distribution without passing...

Date: January 7, 2022
Company: Orthosoft, Inc. dba Zimmer CAS
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Orthosoft, Inc. dba Zimmer CAS directly.

Affected Products

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

Quantity: 14 units US; 132 units OUS

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Orthosoft, Inc. dba Zimmer CAS

Orthosoft, Inc. dba Zimmer CAS has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report