RecallRadar

FDA Device recall Z-2076-2017

Navitrack System - OS Knee Universal, Stereotaxic instrument

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

AgencyFDA Device
Recall numberZ-2076-2017
ClassificationClass II
Statusterminated
Initiated2008-10-28
Published2017-05-24
Last updated2026-09-13 11:54 UTC
CompanyOrthosoft
DistributionCA, 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.