Navitrack System — Class II medical device recall Z-1881-2017
Terminated recall by Orthosoft, Inc. dba Zimmer CAS, reported 2017-05-03, distributed in AZ, CA, CO, FL, GA, IL, IN, KS…. Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software O
| Recall number | Z-1881-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthosoft, Inc. dba Zimmer CAS, Montreal, N/A, Canada |
| Recall initiated | 2011-10-06 |
| Classified | 2017-04-26 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-05-08 |
| Distributed | AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MS, OH, OR, PA, SC, SD, TX, VA, WA, WI |
| Countries outside the US | AT, AU, CA, CO, DE, DK, FR, KR, NZ, RU, TH, ZA |
| Quantity | 105 |
| Reason classes | software |
| Lot numbers | ORTHOSOFT-UNITKR-2.3.2.6 |
| Model numbers | ORTHOSOFT-UNITKR-2 |
Product
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Reason for recall
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.
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-1881-2017. 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.