FDA Device recall Z-2076-2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
- FDA Device
- Class II
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class II recall of Navitrack System - OS Knee Universal, Stereotaxic instrument by Orthosoft, citing 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 iss….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2076-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2008-10-28 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthosoft |
| Distribution | CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA |
Product
Navitrack System - OS Knee Universal, Stereotaxic instrument
Reason
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 .
Identifiers
| code_info | Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (prev…Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42 |
|---|
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-2076-2017%22
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