Recall Register

Orthosoft, Inc. dba Zimmer CAS: FDA recalls

FDA enforcement reports name Orthosoft, Inc. dba Zimmer CAS as the recalling firm in 7 events. The events have 7 product records. The recalls started from 2008 to 2022. All the events are device recalls.

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 .

Enforcement events

7 events, newest first.

FDA enforcement events of Orthosoft, Inc. dba Zimmer CAS
InitiatedProduct (first record)TypeClassRecordsStatus
7 Jan 2022NavitrackER Kit A: Knee, Model Number 20-8000-000-07,DeviceClass II1Ongoing
20 Feb 2017SmartTools Knee System Orthopedic Stereotaxic InstrumentDeviceClass II1Terminated
6 Oct 2011Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement componentsDeviceClass II1Terminated
9 Jun 2009NDI P7 Position Sensor, Stereotaxic InstrumentDeviceClass II1Terminated
28 Oct 2008Navitrack System - OS Knee Universal, Stereotaxic instrumentDeviceClass II1Terminated
20 Jun 2008Navitrack System - OS Knee Universal, Orthopedic Stereotaxic InstrumentDeviceClass III1Terminated
4 Jun 2008Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Orthosoft, Inc. dba Zimmer CAS: events for each product type
TypeEvents
Device7
Orthosoft, Inc. dba Zimmer CAS: events in each class
ClassEvents
Class II6
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

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.

Events by year

FDA enforcement events of Orthosoft, Inc. dba Zimmer CAS, by the year that the recall started. The largest year is 2008, with 3 events.

Official channels

Cite this page

Recall Register. Orthosoft, Inc. dba Zimmer CAS: FDA recalls. https://recallregister.com/firm/orthosoft-inc-dba-zimmer-cas/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Orthosoft, Inc. dba Zimmer CAS have?
Class II: 6 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Orthosoft, Inc. dba Zimmer CAS?
FDA event 89619, which the firm started on 7 Jan 2022. The first product in the record is: NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
How many FDA recalls of Orthosoft, Inc. dba Zimmer CAS have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says 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.