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.

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

Recall #: Z-1559-2020
Affected scope: N/A
Initiated: February 11, 2020

Compiled from official public sources by the publisher. · Updated September 2026

Intellijoint Surgical, Inc. recalled Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage… - a moderate-severity action.

Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage… was recalled by Intellijoint Surgical, Inc. in April 1, 2020. Reason: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.. Check the official notice for the remedy. Verify recall #Z-1559-2020 with the FDA Devices before acting.

The recall

Intellijoint Surgical, Inc. issued this moderate-severity FDA Devices recall-During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth..

Moderate
severity level: Class II
classification: April 1, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1559-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1559-2020
Date reported	April 1, 2020
Date initiated	February 11, 2020
Recalling firm	Intellijoint Surgical, Inc.
Firm location	Waterloo, N/A
Affected scope	N/A
Distribution	Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1559-2020) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1559-2020.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported April 1, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026