FDA-Device2015-06-03Class II

Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

United Surgical Associates
Hazard

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

Sold states
Domestic: HI International; None
Affected count
756
Manufactured in
2235 Pennsylvania St, Fort Wayne, IN, United States
Products
Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1666-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief