FDA Device recall Z-1881-2017
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of tot…
- FDA Device
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of tot… by Orthosoft, citing zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1881-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-10-06 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthosoft |
| Distribution | AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MS, OH, OR, PA, SC, SD, TX, VA, WA, WI |
Product
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Reason
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
Identifiers
| code_info | Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1881-2017%22
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