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Open, Classified

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.

FDA Recall Z-1739-2025 · Posted 2025-05-08

Recalling FirmWANDERCRAFT SAS
Recall StatusOpen, Classified
Product CodePHL
Date Initiated2025-04-03
Product Quantity3

Reason for Recall

Potential for exoskeleton to lose lateral balance and cause patient to fall.

Firm Action

An URGENT SAFETY NOTICE dated 4/3/25 was mailed to consignees. The letter notifies consignees that WANDERCRAFT will be reinforcing their training program for the Atalante X and providing additional instructions by 5/1/25. Until the additional instructions can be provided, users are being instructed to only have certified Atalante X operators maintain the stability of the exoskeleton at all times by keeping at least one hand on the handles throughout the session. Consignees are to share the recall notification with users at their facility and retained for awareness.

Root Cause

Use error

Distribution Pattern

Domestic: PA & NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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