Class II — Intellijoint Surgical, Inc.
| Recalling firm | Intellijoint Surgical Inc. |
|---|---|
| Registered facility | Intellijoint Surgical Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. |
| 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. |
| Quantity | N/A |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada. |
| Initiated | 2020-02-11 |
| Classified | 2020-03-23 |
| Terminated | 2020-06-10 |
| Recall number | Z-1559-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intellijoint Surgical, Inc. (Z-1559-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85016/
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