Townsend Design Custom SPRYSTEP Ankle-Foot Orthosis Recalled for Structural Failure Risk
Townsend Design is recalling 248 units of CUSTOM SPRYSTEP ankle-foot orthotics for potential air pockets that could cause complete structural failure and loss of ankle support.
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 for a medical device with a structural failure risk stemming from material defects. While no injuries or hospitalizations have been reported, the risk-of-harm nature of the defect—complete structural failure could cause falls—meets the High severity criterion for recalled products where injury has not yet been reported.
Plain-English summary
Townsend Design is recalling 248 units of CUSTOM SPRYSTEP, a dynamic ankle-foot orthosis (AFO). The recall was issued due to potential air pockets between layers of material that could lead to complete structural breakage of the device.
The recalled devices are identified by reference numbers 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, and 17C2040. They were distributed throughout the United States, including all 50 states and the District of Columbia, Puerto Rico, and internationally to Canada, New Zealand, Japan, Australia, the Netherlands, and the United Kingdom.
A complete structural failure of the ankle-foot orthosis could result in loss of ankle support and create a fall risk for the user. This is a Class II recall issued by the FDA.
The recalled product
- Product
- CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
- Manufacturer
- Townsend Design
- Affected units
- 248
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 →- HighSPRYSTEP VECTOR KAFO 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
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