Device recall: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Class II FDA enforcement event 89619. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Orthosoft, Inc. dba Zimmer CAS started this device recall on 7 Jan 2022. The firm address in the FDA record is in Montreal. FDA put the recall in Class II. FDA event 89619 has 1 product record. The first FDA enforcement report date is 9 Mar 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
Recalling firm
Orthosoft, Inc. dba Zimmer CAS, Montreal, Canada.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0721-2022 | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, | 14 units US; 132 units OUS | Class II | Ongoing | 9 Mar 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Feb 2017 | SmartTools Knee System Orthopedic Stereotaxic Instrument | Device | Class II | 1 |
| 6 Oct 2011 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in t | Device | Class II | 1 |
| 9 Jun 2009 | NDI P7 Position Sensor, Stereotaxic Instrument | Device | Class II | 1 |
| 28 Oct 2008 | Navitrack System - OS Knee Universal, Stereotaxic instrument | Device | Class II | 1 |
| 20 Jun 2008 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument | Device | Class III | 1 |
| 4 Jun 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0721-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 89619. https://recallregister.com/fda/ii/89619/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.
- What quantity of product is in FDA event 89619?
- The FDA record gives this quantity:
14 units US; 132 units OUS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.