NavitrackER Kit A: Knee, Model Number 20-8000-000-07 recallZ-0721-2022 · Orthosoft, Inc. dba Zimmer CAS · initiated Jan 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthosoft, Inc. dba Zimmer CAS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0721-2022
- Status
- Open, Classified
- Initiated by the company
- Jan 7, 2022
- Recalling firm
- Orthosoft, Inc. dba Zimmer CAS
- Quantity
- 14 units US; 132 units OUS
- Product code
- OLO
- FDA submissions
- K110054
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Product description
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Code information (models, lots, serial numbers)
Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NavitrackER 20-8000-000-07Orthosoft Inc · Orthopedic Stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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