Class 2 Device Recall SYMBIONIC LEG

• Date Initiated by Firm: February 12, 2012
• Date Posted: February 06, 2014
• Recall Status: Terminated on February 06, 2014
• Recall Number: Z-0936-2014
• Recall Event ID: 67249
• Product Classification: Component, external, limb, ankle/foot - Product Code ISH
• 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 device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). 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 than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use.
• Code Information: 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
• FEI Number: 1000519909
• Recalling Firm/ Manufacturer: Ossur Americas, Inc.; 19762 Pauling; Foothill Ranch CA 92610-2611
• For Additional Information Contact: 949-303-3239
• Manufacturer Reason for Recall: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
• FDA Determined Cause: Nonconforming Material/Component
• Action: OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer. OSSUR has inspected and made appropriate modification to all inventory. ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product. For further questions please call (949) 303-3239.
• Quantity in Commerce: 17 units
• Distribution: US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.