Ossur Recalls Symbionic Leg Prostheses Due to Electronics Defect
Ossur is recalling 17 Symbionic Leg prostheses due to a possible defect in a small batch of electronics. The recall affects units distributed in seven US states and DC.
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 is classified as FDA Class II. The source text describes a 'possible defect' in electronics without reporting specific injuries or illnesses, which aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ossur Americas, Inc. is recalling 17 units of the Symbionic Leg, an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The recall was initiated because the devices may have a possible defect in a small batch of electronics.
The Symbionic Leg is a battery-powered, micro-processor controlled prosthetic device composed of the RHEO KNEE and the PROPRIO FOOT. It is intended for continuous use by amputees of low to moderate impact levels. The affected units were distributed in the United States, specifically in the states of Alabama, Georgia, New Jersey, New York, Oklahoma, Pennsylvania, and the District of Columbia.
Consumers with these specific devices should contact Ossur for further instructions. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic…
- Manufacturer
- Ossur Americas, Inc.
- Hazard
- Affected units
- 17
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 (20)
- Item Numbers: SBL12012
- SMBL5250
- SBL12903
- SMBL5270
- SMBL2240
- SMBL5280
- SMBL3260
- SMBL7290
- SMBL3280
- Serial Numbers: 321195
- 321201
- 710326
- 710328
- 710335
- 710339
- 710340
- 710353
- 710355
- 710365
- 710390
Distribution
Related recalls
Same manufacturer · Ossur Americas, Inc.
See all →- HighOssur Recalls Symbionic Leg Due to Battery Warning Failure
FDA (Devices) · 2014-03-05
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