Leckey MyWay Gait Trainer/Walker (2021-03-08)

Starting date:

March 8, 2021

Posting date:

March 25, 2021

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-75199

Last updated: 2021-03-25

• Reason
• Affected products

Affected Products 

Leckey MyWay Gait Trainer/Walker

Reason

The rear legs of the MyWay walker each have a boss into which castors are screwed. This boss can become loose causing the castor to loosen from the rear leg of the chassis. Investigations have confirmed that this is due to variability in the weld process used to attach the boss to tube.  The manufacturer has identified a potential for patient harm.  In the interest of user safety, a decision has been taken to issue a Field Safety Notice proactively (FSN-01-03-21). This will involve a MyWay Walker Rear Leg replacement to be carried out in the field.

Affected products