Z-1559-2020Class II

Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) -

Name: Z-1559-2020 Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) -
Creator: Intellijoint Surgical, Inc.
Published: 2020-02-11
License: https://open.fda.gov/license/

Intellijoint Surgical Inc. / initiated 2020-02-11 / Terminated / root cause: software

FDA source

Intellijoint Surgical, Inc. began a recall of Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical... on 2020-02-11. FDA classified it as Class II and gives the reason as "During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1559-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-11
Posted: 2020-03-23
Terminated: 2020-06-10
Recalling firm: Intellijoint Surgical Inc.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Root cause tag: software
FDA root cause: Software design
Action: The firm notified the Intellijoint Surgical Sales Representatives that manage the affected sites. Communications were sent via email on 2/11/2020. Sales reps are responsible for verbally communicating the correction to affected users within their respective service areas. Users were to be advised of the following: (1) Until a Software update is provided, users should consult the Instructions for Use (Section 6.9.4 Lateral Femoral Condyle Definition (pg. 42) and Section 6.9.5 Medial Femoral Condyle Definition (pg. 42)) and follow the steps outlined for the acquisition of data used to calculate resection depth. (2) Resection depth should be verified by manual methods (calipers, angel wings etc.) for each case. (3) Due to the low risk and nature of the error, Intellijoint is not requesting that affected product be returned unless requested by the customer. Should the customer/user wish to return affected devices, please contact Sankavi Muralitharan ([email protected]) or Breanne Cuddington, Senior Regulatory Affairs Associate, at [email protected]; 1-888-232-2634 ex. 2234. A software update is under development to correct for this error. The expected release date for the update is February 29, 2020, at which time Intellijoint Sales Representatives will update all affected systems with the new software by March 30, 2020.
Distribution: Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
Product codes and lots: Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1559-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1559-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-23

Product code OLO

K191507Class IIIntellijoint® Navigation SystemIntellijoint Surgical, Inc. / cleared 2019-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)