NavitrackER Kit A: Knee recall: Sterility Concern
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Why was NavitrackER Kit A: Knee 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
- Product
- NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Quantity
- 14 units US; 132 units OUS
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
- Recall date
- March 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)