FDA recall Z-1330-2022

Product

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

Reason for recall

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.

Distribution

Worldwide distribution including US nationwide (including Puerto Rico).

Key facts

Status

Terminated

Initiation date

2022-05-30

Report date

2022-07-13

Termination date

2024-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foothill Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2022