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U.S. Department of Health and Human Services

Class 2 Device Recall The SYMBIONIC LEG

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 Class 2 Device Recall The SYMBIONIC LEGsee related information
Date Initiated by FirmOctober 15, 2012
Date PostedFebruary 26, 2014
Recall Status1 Terminated 3 on February 28, 2014
Recall NumberZ-1097-2014
Recall Event ID 67250
ProductThe SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: 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 Symbionic Item Numbers:   SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913  Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322   
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 is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
FDA Determined
Cause 2		Other
ActionOssur 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.
Quantity in Commerce144 units
DistributionUS Nationwide distribution.
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.
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