Recall Z-2354-2024

Reason for recall

The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury

FDA-determined cause: Process control

Action taken

Drive DeVilbiss Healthcare ( Drive ) issued Urgent Medical Device Recall letter on 6/14/24 to Distributors and End-Users via email. Letter states reason for recall, health risk and action to take: Please take the following three actions immediately: 1)Identify any inventory in your possession of 791BL and 791RD Nitro" Glide Knee Walkers containing serial numbers beginning with 21S, and ensure that they are placed in a location that will prevent sale or rental to an end user. 2) Go to https://www.recallrtr.com/kneewalker and enter your Unique Customer Code, located on the first page of this notice, directly below your address in bold type. Using that code on the website, you will be able to: a. Confirm the quantity of affected units in your possession (i.e., units that contain a serial number beginning with 21S); b. Request postage-paid mailing labels and packing material to return the affected units; c. Order replacement products; and d. Fill out a web form to acknowledge receipt of and compliance with the recall. If you experience any issues with the website or wish to communicate via phone, Drive has established a dedicated Customer Service phone number, (877) 206-1171, which will be available Monday through Friday, from 7:30 a.m. to 5:00 p.m. Central Time. You can also contact us via email regarding this recall at kneewalker@realtimeresults.net. 3) Please contact any customer/end user who purchased or rented an affected unit and provide them notice of and instructions for compliance with the recall. The recall website will also be enabled to assist end-users with registering for the recall, returning their affected unit, and receiving a replacement of the unit. On the website, you will also have the option to provide your customer list so that notification of end-users may be performed on your behalf.