Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mob...
FDA Recall #Z-1739-2025 — Class II — April 3, 2025
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.
Reason for Recall
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Recalling Firm
WANDERCRAFT SAS — Paris, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3
Distribution
Domestic: PA & NY.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.