Recall Z-1687-2021 ยท ITJ Walker, Mechanical
James Leckey Design Ltd
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
| Date | Mar 1, 2021 |
| Status | Open, Classified |
| Reason | Due to a failure of the welds, the casters detached from the rear legs of the walker. |
| Root cause | Device Design |
| Action | On 03/29/2021, the Recalling Firm and its U.S. Distributor sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via mail informing customers that: 1. The rear legs of the walker each have a boss into which castors are screwed. The Recalling Firm has had reports of these bosses coming loose and castors detaching from the rear legs. 2. The rear leg assembly consists of an aluminum tube with bosses welded at either end. Our investigations have identified a common cause of the field issues as a failure of the weld between the tube and the bottom boss. 3. The weld is fabricated by weldin |
| Quantity | 2,719 walkers |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of CA and WI and the countries of Italy, Norway, Australia, Czechia, Netherlands, Denmark, New Zealand, Japan, United Arab Emirates, Qatar, Croatia, Spain, Poland, Russia, South Africa, Taiwan, Saudi Arabia, Chemitec, Centre Harika, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.