Health product recall

Intellijoint KNEE Software Application (2020-02-11)

Starting date:
February 11, 2020
Posting date:
March 6, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72487

Last updated: 2020-03-10

Affected Products

Intellijoint KNEE Software Application

Reason

The Intellijoint KNEE System may incorrectly report femoral resection depth due to a fault state identified in the underlying algorithm used to calculate resection depth. Irregular condyle topology, lifting the Probe during condyle definition, or capture of an insufficient number of points may affect the resection depth reported.

Affected products

Intellijoint KNEE Software Application

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

000-0547

Companies
Manufacturer
Intellijoint Surgical Inc.
809 Wellington Street North, Unit 2
Kitchener
N2H 5L6
Ontario
CANADA