FDA recall Z-1559-2020

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.

Reason for recall

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

Distribution

Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.

Key facts

Status

Terminated

Initiation date

2020-02-11

Report date

2020-04-01

Termination date

2020-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waterloo, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1559-2020