_Incident · Recall_

# FDA Class 2 recall of Oessur Total Knee 2100 due to faulty back links

Canonical ID: `079fe547-7b84-4312-8bc0-fc2bbb6f26c8`

- **Occurred:** 2011-02-11
- **Kind:** `recall`
- **Status (derived):** active
- **Model:** [Rheo Knee](/models/embla-rheo-knee.md) (id: `a1cbcd61-8673-4bdf-8dc0-eee1fea9d6e8`)
- **Company:** [Embla Medical hf](/companies/embla-medical.md)

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.

## Sources (1)

1. **FDA** · https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97954 · 2011-03-25

## Status history

- **active** · 2026-08-16 · agent:recon

## Common questions

### 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 is the recorded robot involved in this incident.

### 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.


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