Reported Mar 9, 2022 · Ongoing
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Orthosoft, Inc. dba Zimmer CAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthosoft, Inc. dba Zimmer CAS · 3300-75 Queen St · Montreal · N/A
Is this the product you have?
- NavitrackER Kit AKnee, Model Number 20-8000-000-07
- Lot codes and dates
- Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
- Amount recalled
- 14 units US; 132 units OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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