Recall Z-0936-2014 ยท ISH Component, External, Limb, Ankle/Foot
Ossur Americas, Inc.
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-ti
| Date | Feb 6, 2014 (initiated Feb 12, 2012) |
| Status | Terminated |
| Reason | OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. |
| Root 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 | 17 units |
| Distribution | US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.