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
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
Leckey MyWay Gait Trainer/Walker (2021-03-08)
Lot or serial number
LEC/262983
LEC/264958
LEC/267877
Model or catalog number
173-1600
173-2600
173-3600
Companies
- Manufacturer
-
JAMES LECKEY DESIGNS LTD
A BALLINDERRY ROAD,
LISBURN
BT2825A
IRELAND