Home / Recalls / Medical Devices
Ossur Americas recalls OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Recalled July 13, 2022 · FDA recall Z-1330-2022 · Ossur Americas
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. · FDA Class II
Units
410 devices
Sold at
Worldwide distribution including US nationwide (including Puerto Rico).
Description
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.
Product
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Manufacturer(s)
Ossur Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →