Ossur Americas recalls OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

Recall date

May 30, 2022

Source

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

Recall number

Z-1330-2022

FDA classification

Class II

Brand / firm

Ossur Americas

Sold / distributed

Worldwide distribution including US nationwide (including Puerto Rico).

Why it was recalled

Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

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 VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.