Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-
Summary
The FDA issued a Class II for Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory by WANDERCRAFT SAS. Reason: Potential for exoskeleton to lose lateral balance and cause patient to fall..
Details
Source
Device Recall
External ID
Z-1739-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.
Lot/Code Info: UDI: (01)3665965000129(21)V5_ABP(11)AA06JJ, (01)3665965000129(21)V5_ACH(11)AA09JJ, (01)3665965000129(21)V5_ADO(11)AA02JJ. No model or serial number.
Quantity Affected: 3
Reason for Recall
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Distribution
Domestic: PA & NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-03
Company
Paris, N/A
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 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
WANDERCRAFT SAS has 4 FDA actions in our database, including 1 recall and 3 clearances.
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 (WANDERCRAFT SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WANDERCRAFT SAS have FDA actions?
WANDERCRAFT SAS has 4 FDA actions in our database, including 1 recall and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1739-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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