FDA Class 2 recall of Oessur Total Knee 2100 due to faulty back links
[RECALL]Feb 11, 2011 · Embla Medical hf · Rheo Knee · Germany, Europe
Failure Mode
RECALL
Event Date
Feb 11, 2011
Primary Entity
Embla Medical hf
Robotic Platform
Rheo Knee
Jurisdiction / Location
Germany, Europe
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Oessur initiated a voluntary recall of 142 units of the Total Knee Model 2100 produced from October 19, 2010 to January 21, 2011, after finding that some units contained back links that may compromise knee function prematurely. The recall was distributed worldwide across the US, Europe, Australia, Canada, and Japan. FDA determined the cause as process design.
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=97954
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97954
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Details
Incident Context & FAQ
What happened in FDA Class 2 recall of Oessur Total Knee 2100 due to faulty back links?
Oessur initiated a voluntary recall of 142 units of the Total Knee Model 2100 produced from October 19, 2010 to January 21, 2011, after finding that some units contained back links that may compromise knee function prematurely. The recall was distributed worldwide across the US, Europe, Australia, Canada, and Japan. FDA determined the cause as process design.
When did this incident occur?
The incident is recorded as occurring on February 11, 2011 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 Oessur Total Knee 2100 due to faulty back links?
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 Oessur Total Knee 2100 due to faulty back links?
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 Oessur Total Knee 2100 due to faulty back links?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.