Orthosoft, Inc. dba Zimmer CAS: Medical Device Recall in 2022 - (Recall #: Z-0721-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 7, 2022

Date Posted: March 9, 2022

Recall Number: Z-0721-2022

Event ID: 89619

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.

Status: Ongoing

Product Quantity: 14 units US; 132 units OUS

Code Information:

Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated