NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Recall
- Recall Number
- Z-0721-2022
- Event Number
- 89619
- Firm
- Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada
- FEI Number
- 3003714383
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 7, 2022
Description
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
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.
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 [email protected].
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
14 units US; 132 units OUS