The Symbionic Leg is an integrated prosthetic leg for recall
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and…
Why was The Symbionic Leg is an integrated prosthetic leg for recalled?
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413
- Product
- The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and…
- Recalling firm
- Ossur Americas, Inc.
- Quantity
- 17 units
- Distribution
- US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
- Recall date
- February 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)