FDA Device recall Z-2075-2017
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
- FDA Device
- Class III
- terminated
- Published 2017-05-24
On 2017-05-24 the FDA classified a Class III recall of Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument by Orthosoft, citing ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2075-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2008-06-20 |
| Published | 2017-05-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthosoft |
| Distribution | CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI |
Product
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Reason
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Identifiers
| code_info | Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Softw…Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82 |
|---|
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-2075-2017%22
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