The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYM
FDA device recall Z-1097-2014 · posted 2014-02-26 · Terminated
Recall details
- Recalling firm
- Ossur Americas, Inc.
- Reason for recall
- OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
- Action taken
- Ossur Americas contacted all affected customers via phone on October 15, 2012 informing them that a software update for this product is required, along with the recommended instructions to return the product. A loaner prosthetic will be provided to the patient while the software update is being implemented.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 144 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2012-10-15
- Date posted
- 2014-02-26
- Date terminated
- 2014-02-28
- Location
- Foothill Ranch, CA
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