FDA Device recall Z-1559-2020
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer…
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer… by Intellijoint Surgical, citing during total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1559-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-11 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intellijoint Surgical |
| Distribution | US |
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
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Identifiers
| code_info | Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1559-2020%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.