FDA-Device2022-07-13Class II
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
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.
Sold states
Worldwide distribution including US nationwide (including Puerto Rico).
Affected count
410 devices
Manufactured in
27051 Towne Centre Dr, N/A, Foothill Ranch, CA, United States
Products
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2022Don't want to check this manually?
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