ClearanceBrief
Recall Z-2355-2024 ยท ITJ Walker, Mechanical

Medical Depot Inc.

Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)

DateJul 12, 2024 (initiated Jun 14, 2024)
StatusOpen, Classified
ReasonThe tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
Root causeProcess control
ActionDrive 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 no
Quantity667 units
DistributionNationwide Foreign: Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.