Ossur Variflex Suba Junior prosthetic foot may crack under impact
Ossur has recalled 410 Variflex Suba Junior prosthetic feet due to cracking and breaking under impact stress. The device is designed for children and adolescents worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving structural failure of a prosthetic foot for children and adolescents. The device cracks and breaks under impact, twisting, and bending—normal mobility activities—creating a direct risk of device failure and potential injury, even though specific injury reports are not mentioned in the recall notice.
Plain-English summary
Ossur Americas has recalled 410 Variflex Suba Junior prosthetic feet and ankles for children and adolescents. The recall was issued after complaints that the prosthetic foot cracks and breaks when exposed to sudden high-impact twisting or bending during normal use.
The affected devices are distributed worldwide, including throughout the United States and Puerto Rico. Specific product codes and UDI-DI codes are listed in FDA recall Z-1330-2022.
Consumers with affected devices should contact Ossur Americas or their prosthetics provider for evaluation and potential replacement. The prosthetic foot is essential equipment for mobility and safety in children and adolescents.
The recalled product
- Product
- OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
- Manufacturer
- Ossur Americas
- Category
- Medical Device — Prosthetic foot
- Affected units
- 410
Distribution
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