NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
- Recall Initiated
- January 7, 2022
- Recall Number
- Z-0721-2022
- Quantity
- 14 units US; 132 units OUS
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Lot / Code Info
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Root Cause
Under Investigation by firm
Action Taken
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.