Recall Z-0721-2022— Orthosoft, Inc. dba Zimmer CAS

Name: FDA recall Z-0721-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

Class II · Ongoing

Class II FDA medical device recall by Orthosoft, Inc. dba Zimmer CAS, initiated 2022-01-07. It names one FDA 510(k) clearance: K110054. Product: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,. 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..

Recalling firm: Orthosoft, Inc. dba Zimmer CAS
Classification: Class II
Status: Ongoing
Initiated: 2022-01-07
Firm location: Montreal, Canada

510(k) clearances named in this recall

1 on FDA's record

K110054 — NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCEZimmer Cas·cleared 2011-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.