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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 334
Distribution
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
See all →- HighTownsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk
FDA (Devices) · 2024-01-17
- HighSPRYSTEP VECTOR Ankle-Foot Orthosis Recalled for Structural Failure Risk
FDA (Devices) · 2024-01-17
Same hazard · structural failure
See all →- High
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