Intellijoint Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1559-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
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.
Class II
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
Voluntary: Firm initiated