FDA Medical Device Recalls (openFDA)
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 number
- Z-1559-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-02-11
- Posted
- not on file
- Terminated
- 2020-06-10
- Reason
- During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
- 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 (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.
- Quantity
- not on file
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
- Lot, serial or model codes
- Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
- 510(k) numbers
- K191507
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3010822102
- Firm city
- Waterloo
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28