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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85016

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 11, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intellijoint Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1559-2020
Recall number
Z-1559-2020
Initiated
February 11, 2020
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software may

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.

Distribution pattern

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