Device recall: Navitrack System - OS Knee Universal, Stereotaxic instrument
Class II FDA enforcement event 75613. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .
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 28 Oct 2008. The firm address in the FDA record is in Montreal. FDA put the recall in Class II. FDA event 75613 has 1 product record. The first FDA enforcement report date is 24 May 2017. The record gives the status Terminated, with the termination date 15 May 2017.
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.
Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New…
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-2076-2017 | Navitrack System - OS Knee Universal, Stereotaxic instrument | 153 | Class II | Terminated | 24 May 2017 |
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 2008
- 18
- Share of these events in Class II
- 89%
- 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 |
|---|---|---|---|---|
| 7 Jan 2022 | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, | Device | Class II | 1 |
| 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 |
| 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-2076-2017The 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.
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Cite this page
Recall Register. FDA enforcement event 75613. https://recallregister.com/fda/ii/75613/. 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:
Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New…
- What quantity of product is in FDA event 75613?
- The FDA record gives this quantity:
153
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2008 have the same class?
- 89% of the 18 device events that started in 2008 are in Class II.