Z-0721-2022Class II

NavitrackER Kit A: Knee, Model Number 20-8000-000-07

Name: Z-0721-2022 NavitrackER Kit A: Knee, Model Number 20-8000-000-07
Creator: Orthosoft, Inc. dba Zimmer CAS
Published: 2022-01-07
License: https://open.fda.gov/license/

Zimmer CAS / initiated 2022-01-07 / Open, Classified / root cause: sterility

FDA source

Orthosoft, Inc. dba Zimmer CAS began a recall of NavitrackER Kit A: Knee, Model Number 20-8000-000-07 on 2022-01-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0721-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-07
Posted: 2022-03-03
Recalling firm: Zimmer CAS
Product: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: 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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 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.
Product codes and lots: Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0721-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0721-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-09	2022-03-03

Product code OLO

K110054Class IINavitrack System - Os Knee Universal, Cas Same Incision Tibia ReferenceZimmer Cas / cleared 2011-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)