FDAMay 30, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

ossur americasossur

UPCs

569097738720156909773872185690977387225569097738723256909773872495690977387256569097738726356909773872705690977387287569097738729456909773873005690977387317

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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