Home / Recalls / Intellijoint Surgical, Inc. / Z-1559-2020

Z-1559-2020 Class II Terminated

Recalled by Intellijoint Surgical, Inc. — Waterloo, N/A

Recall Details

Product Type: Devices
Report Date: April 1, 2020
Initiation Date: February 11, 2020
Termination Date: June 10, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

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 Pattern

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

Code Information

Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.