Z-1097-2014Class II

The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees

Name: Z-1097-2014 The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
Creator: Ossur Americas, Inc.
Published: 2012-10-15
License: https://open.fda.gov/license/

Ossur Americas / initiated 2012-10-15 / Terminated

FDA source

Ossur Americas, Inc. began a recall of The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous... on 2012-10-15. FDA classified it as Class II and gives the reason as "OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1097-2014
Classification: Class II
Status: Terminated
Initiated: 2012-10-15
Posted: 2014-02-26
Terminated: 2014-02-28
Recalling firm: Ossur Americas
Product: The 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.
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 root cause: Other
Action: 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.
Quantity in commerce: 144 units
Distribution: US Nationwide distribution.
Product codes and lots: Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1097-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1097-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-26

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)