The Recall Desk
HighFDA (Devices)·Z-0672-2024·Announced 2024-01-17

SPRYSTEP VECTOR KAFO ankle-foot orthosis recalled for structural failure risk

The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a structural failure risk in an orthotic device. The source describes potential for complete structural breakage but does not report any actual injuries or hospitalizations, qualifying it as a risk-of-harm product without confirmed injury reports per the severity rubric.

Plain-English summary

Townsend Design is recalling the SPRYSTEP VECTOR KAFO, a custom-made dynamic ankle-foot orthosis (KAFO), model numbers 17VKCUS and 17VKCUSX. A total of 334 units have been recalled.

The orthosis is being recalled because air pockets can form between layers of material, which may result in complete structural breakage of the device.

The affected devices have been distributed throughout the United States, Puerto Rico, and internationally to Canada, New Zealand, Japan, Australia, the Netherlands, and the United Kingdom.

The recalled product

Product
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Manufacturer
Townsend Design
Category
Medical Device — Orthotic Devices
Hazard
Affected units
334

Distribution

Distributed in 48 states:

Part of a larger recall action

This product is one of 3 recalled by Townsend Design under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Townsend Design

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Same hazard · structural failure

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