Class 2 Device Recall NavitrackER

• Date Initiated by Firm: January 07, 2022
• Create Date: March 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0721-2022
• Recall Event ID: 89619
• 510(K)Number: K110054
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
• Code Information: Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
• Recalling Firm/ Manufacturer: Orthosoft, Inc. dba Zimmer CAS; 3300-75 Queen St; Montreal Canada
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On January 7, 2022, the firm issued Urgent Medical Device Recall letters to all affected consignees. Customers were instructed to assist Zimmer Biomet sales representatives and quarantine all affected product. Product will be removed from customer facilities. Customers are responsible for forwarding the recall notice to any accounts who received further distribution. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 14 units US; 132 units OUS
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OLO