Ossur H / F recalls Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic o…

Recall date

March 14, 2016

Source

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

Recall number

Z-1512-2016

FDA classification

Class II

Brand / firm

Ossur H / F

Sold / distributed

Distribution US Nationwide and Hong Kong

Why it was recalled

There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

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

What was recalled

Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.