Townsend Design recalls SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

Recall date

September 23, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0672-2024

FDA classification

Class II

Brand / firm

Townsend Design

Sold / distributed

US: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA QC SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico, OUS: None OUS: Canada, New Zealand, Japan, Australia, Netherlands, United Kingdom

Why it was recalled

Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX