Navitrack System — Class II medical device recall Z-2076-2017
Terminated recall by Orthosoft, Inc. dba Zimmer CAS, reported 2017-05-24, distributed in CA, FL, GA, IL, IN, KS, NC, NY…. Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software ver
| Recall number | Z-2076-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosoft, Inc. dba Zimmer CAS, Montreal, Canada |
| Recall initiated | 2008-10-28 |
| Classified | 2017-05-12 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-05-15 |
| Distributed | CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA |
| Countries outside the US | AT, AU, BR, CA, CH, CN, CZ, DE, ES, FR, GB, IL, IT, LB, LU, NL, NZ, SE |
| Quantity | 153 |
| Reason classes | software |
| Serial numbers | 2.1.6.0.2, 2.2.0.82, 2.2.1.3 |
Product
Navitrack System - OS Knee Universal, Stereotaxic instrument
Reason for recall
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 .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2076-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.