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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67249

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 12, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ossur Americas, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0936-2014
Recall number
Z-0936-2014
Initiated
February 12, 2012
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas, Inc.
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.

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

Distribution pattern

US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.

Field note

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