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Incident · Recall

FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure

Össur initiated a Class 2 recall of 141 units of the Total Knee Junior prosthetic knee produced between November 2008 and April 2009. The balancing units could fail under extreme use over a long period (estimated 4-6 years). No incidents or injuries were reported at the time of recall. The recall was terminated on February 6, 2012.

Occurred 2009-08-10 · Rheo Knee · Embla Medical hf · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure

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Sources (1)

  1. FDA MAUDE Database · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=84735 · 2012-02-06

Status history

  • Active · 2026-07-28 · agent:recon

Common questions

What happened in FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure?
Össur initiated a Class 2 recall of 141 units of the Total Knee Junior prosthetic knee produced between November 2008 and April 2009. The balancing units could fail under extreme use over a long period (estimated 4-6 years). No incidents or injuries were reported at the time of recall. The recall was terminated on February 6, 2012.
When did this incident occur?
The incident is recorded as occurring on August 10, 2009 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure?
Rheo Knee is the recorded robot involved in this incident.
Has anyone responded to FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-07-28

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-28

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure.

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Canonical ID 015ef41a-2185-4ffb-b87c-67bcecb5391c