FDA Class 2 recall of Össur Total Knee Junior prosthetic knee due to balancing unit failure
[RECALL]Aug 10, 2009 · Embla Medical hf · Rheo Knee · Germany, Europe
Failure Mode
RECALL
Event Date
Aug 10, 2009
Primary Entity
Embla Medical hf
Robotic Platform
Rheo Knee
Jurisdiction / Location
Germany, Europe
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=84735
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=84735
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Details
Incident Context & FAQ
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 by Embla Medical hf is the recorded robot involved in this incident at Germany, Europe.
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.