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Incident · Recall

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.

Occurred 2011-02-11 · 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 Oessur Total Knee 2100 due to faulty back links

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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.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-16

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-16

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 Oessur Total Knee 2100 due to faulty back links.

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