Recall Z-1559-2020 · OLO Orthopedic Stereotaxic Instrument
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.
| Date | Feb 11, 2020 |
| Status | Terminated |
| 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 calcul |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191507 | Intellijoint® Navigation System Intellijoint Surgical, Inc., Oct 1, 2019 |