Ossur recalls children's and adolescent foot and ankle prostheses (VARIFLEX SUBA JUNIOR) due to cracks that can break under sudden twisting or bending forces.
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.
Ossur is recalling its VARIFLEX SUBA JUNIOR foot and ankle prostheses for children and adolescents because they can crack under sudden high-impact twisting or bending. This crack risk could lead to the prosthesis breaking during normal use, potentially causing injury.
The prosthetic foot can crack when subjected to sudden high-impact twisting or bending forces. This crack risk occurs during normal use, such as when walking or running, and could cause the prosthesis to break unexpectedly.
Children and adolescents who own or use the Ossur VARIFLEX SUBA JUNIOR foot and ankle prostheses are affected. Those with active mobility or frequent physical activity are at higher risk of the prosthesis breaking.
Check for the model numbers listed in the recall: VARIFLEX JUNIOR C1, C2, or C3 with sizes S16 through S24. These prostheses were sold between 2019 and 2023.
Inspect the prosthetic foot for visible cracks or damage before using it.
If cracks are found, stop using the prosthesis right away to prevent injury.
The recall is due to complaints about the prosthetic foot cracking under sudden high-impact twisting or bending forces, which could lead to breakage during normal use.
Check the model numbers listed in the recall: VARIFLEX JUNIOR C1, C2, or C3 with sizes S16 through S24. These prostheses were sold between 2019 and 2023.
If you find a crack, stop using the prosthesis immediately to prevent injury.
We’ve drafted a message you can send Ossur to request your refund or repair — edit it as you like.
Subject: Recall Z-1330-2022 — Ossur Ossur Hello, I own a Ossur that is covered by recall Z-1330-2022 from Ossur. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
