Intellijoint Surgical, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Intellijoint Surgical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
Intellijoint Surgical, Inc. is recalling Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intel due to During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Recommended Action
Per FDA guidance
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 (s.muralitharan@intellijointsurgical.com) or Breanne Cuddington, Senior Regulatory Affairs Associate, at b.cuddington@intellijointsurgical.com; 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026