Lower riskMedical device recall · FDA · Published January 7, 2022
Zimmer CAS NavitrackER Knee Kit A: Infection Risk from Sterility Issues
Zimmer CAS recalls NavitrackER Knee Kit A (Model 20-8000-000-07) due to potential infection from insufficient sterilization. Affected units sold with lot 110221A1 and UDI number (01)00889024304222.
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.
Take action
Contact the company
📍Recalling firmOrthosoft, Inc. dba Zimmer CAS3300-75 Queen St · Montreal, Canada
“Zimmer CAS NavitrackER Knee Kit A: Infection Risk from Sterility Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61305-zimmer-cas-navitracker-knee-kit-a-infection-risk-from-sterility. Based on FDA recall #Z-0721-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0721-2022%22&limit=1).
The FDA announced on Jan. 7, 2022, that Orthosoft, Inc. dba Zimmer CAS is recalling the NavitrackER Kit A: Knee due to insufficient sterility risks. The agency issued recall number Z-0721-2022 for the device distributed worldwide.
How to tell if you have it
Brand: Zimmer CAS
Product: NavitrackER Kit A: Knee
Model Number: 20-8000-000-07
UPC: 00889024304222
Lot number: 110221A1
UDI Number (01)00889024304222 (17)231103(10)110221A1
The hazard
The product was released without passing sterilization results, potentially leading to insufficient sterility. The highest severity risk is infection requiring surgical intervention.
Context
GovInfoNow's records show other recent recalls of similar products include Medline Recalls Knee Surgery Kits Due to Sterility Risk (2026-06-10) and Zimmer Sterile Tourniquet Hoses: Potential Sterility Breach Risk (2026-06-09). Zimmer Sterile Tourniquet Hoses Recall: Sterility Breach Risk was also reported on 2026-06-09.
How to tell if you have this one
Check for the model number 20-8000-000-07 on the kit. Affected units have lot number 110221A1 and UDI number (01)00889024304222.
Brand
Zimmer CAS
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number, lot number, and UDI number to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, New York, Ohio, Tennessee, Texas.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0721-2022 (January 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0721-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.