Ossur Recalls Symbionic Leg Due to Battery Warning Failure
Ossur is recalling 144 Symbionic Leg prosthetics because they fail to display a low battery warning before powering down.
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: The recall involves a risk-of-harm product (prosthetic leg) where the failure to warn of low battery could lead to sudden power loss and potential injury, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Ossur Americas, Inc. is recalling 144 units of the Symbionic Leg, an integrated prosthetic leg designed for transfemoral and knee disarticulation amputees. The recall is being conducted because the device is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
The affected units were distributed nationwide in the United States. The Symbionic Leg is intended for continuous use by amputees of low to moderate impact levels who weigh less than 125 kg for foot categories 25 and 30, and less than 100 kg for foot categories 22, 23, and 24. The system is not intended for athletic use.
Consumers should check their Symbionic Leg item numbers and serial numbers against the list provided in the official recall notice to determine if their unit is affected. Affected item numbers include SBL12002, SBL12006, SBL12012, SBL12016, SBL12102, SBL12112, SBL12202, SBL12212, SBL12902, SBL12903, SBL12912, and SBL12913. Affected serial numbers include 321245, 322095, 322276, 322894, and the range 710119-710322.
The recalled product
- Product
- The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less…
- Manufacturer
- Ossur Americas, Inc.
- Category
- Medical Device — Prosthetic Limb
- Affected units
- 144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 322095
- 322276
- 322894
- 710119-710322
Distribution
Distributed nationwide across the United States.
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