Recall Z-1330-2022— Ossur Americas
Class II · Terminated
Class II FDA medical device recall by Ossur Americas, initiated 2022-05-30, terminated 2024-12-27. FDA's recall record names no specific 510(k) clearance for this event. Product: OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.. Reason: 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..
- Recalling firm
- Ossur Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-05-30
- Terminated
- 2024-12-27
- Firm location
- Foothill Ranch, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.