OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Reported: July 13, 2022 Initiated: May 30, 2022 #Z-1330-2022
Product Description
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.
Details
- Recalling Firm
- Ossur Americas
- Units Affected
- 410 devices
- Distribution
- Worldwide distribution including US nationwide (including Puerto Rico).
- Location
- Foothill Ranch, CA
Frequently Asked Questions
What product was recalled? ▼
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.. Recalled by Ossur Americas. Units affected: 410 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1330-2022.
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