Intellijoint Navigation System — Class II medical device recall Z-1559-2020
Terminated recall by Intellijoint Surgical, Inc., reported 2020-04-01, distributed nationwide. During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
| Recall number | Z-1559-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intellijoint Surgical, Inc., Waterloo, N/A, Canada |
| Recall initiated | 2020-02-11 |
| Classified | 2020-03-23 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2020-06-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | software |
Product
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
Reason for recall
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
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-1559-2020. 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.