Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada NavitrackER Kit A: Knee, Model Number 20-8000-000-07, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Brand
Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada
Lot Codes / Batch Numbers
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Products Sold
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Orthosoft, Inc. dba Zimmer CAS 3300-75 Queen St Montreal Canada is recalling NavitrackER Kit A: Knee, Model Number 20-8000-000-07, due to The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026