Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67250

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

Open FDA event record

Event summary

Timeline bucket
October 15, 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. 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.

Z-1097-2014
Recall number
Z-1097-2014
Initiated
October 15, 2012
Classification
Class II
Status
Terminated
Recalling firm
Ossur Americas, Inc.
Quantity
144 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

US Nationwide distribution.