Recall Z-1687-2021

Reason for recall

Due to a failure of the welds, the casters detached from the rear legs of the walker.

FDA-determined cause: Device Design

Action taken

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 welding through a hole in the tube to create the bond and the weld is then continued to completely fill the hole. The boss is welded at either side of the tube, and the welds are then smoothed off on the outside of the tube prior to painting, obscuring the weld on the finished product. The failure is due to variations in the manual weld process, primarily due to variability in the weld parameters used. This led to the solid aluminum boss not being heated sufficiently in the weld process, thereby creating a weak bond. Process controls did not prevent the process failure or detect that there was an issue prior to dispatch. 4. On evaluation of the failure, it is seen if the weld breaks, initially the castor boss will be retained in the tube by the roughened weld surface between the tube and boss. However over, the boss will potentially work its way loose, or through repeated use the roughening will be worn away and allow the castor boss to come loose. Use of this product may result in the unexpected detachment of the caster which could result in a fall and potential injury due to a fall. Customers are instructed to: -Immediately examine their inventory and quarantine product subject to the recall. -If they further distributed the affected products, notify them of the product recall by forwarding/including a copy of this recall notification. -Complete and return the Acknowle