# FDA recall Z-1330-2022

> **Ossur Americas** · Class II · device recall initiated 2022-05-30.

## 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

- **Recall number:** Z-1330-2022
- **Recalling firm:** Ossur Americas
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1330-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1330-2022. Source: US FDA. Licensed CC0.

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