Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0721-2022

January 07, 2022

Class II

Product summary

Firm
Orthosoft, Inc. dba Zimmer CAS
Event
Event 89619
Status
Ongoing
Classification
Class II
Quantity
14 units US; 132 units OUS
Official record key
device-enforcement:Z-0721-2022

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.