Z-2354-2024Class II

Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and...

Name: Z-2354-2024 Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and...
Creator: Medical Depot Inc.
Published: 2024-06-14
License: https://open.fda.gov/license/

Medical Depot Inc. / initiated 2024-06-14 / Open, Classified / root cause: manufacturing process

FDA source

Medical Depot Inc. began a recall of 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... on 2024-06-14. FDA classified it as Class II and gives the reason as "The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2354-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-14
Posted: 2024-07-12
Recalling firm: Medical Depot Inc.
Product: 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: 791BL (Blue)
Product code: ITJ Walker, Mechanical
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. 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.
Quantity in commerce: 875 units
Distribution: Nationwide Foreign: Canada
Product codes and lots: UPC: 822383019093 (791BL) All serial numbers beginning with 21S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2354-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2354-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12
Z-2355-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)