Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide thro
Summary
The FDA issued a Class II for Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the by Medical Depot Inc.. Reason: The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury.
Details
Source
Device Recall
External ID
Z-2355-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: UPC: 822383019086 (791RD) All serial numbers beginning with 21S
Quantity Affected: 667 units
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
Distribution
Nationwide Foreign: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-14
Company
Port Washington, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medical Depot Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medical Depot Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Depot Inc. have FDA actions?
Medical Depot Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2355-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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