Reported Oct 28, 2015 · Terminated

ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US)…

ConforMIS, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ConforMIS, Inc. · 28 Crosby Dr · Bedford, MA · 01730-1402

Is this the product you have?

  • ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2
  • Right Medial Catalog NumberM57230600220 (US) M5723INT0600220 (OUS)
Lot codes and dates
  • Serial Numbers (US)
    • 0354902
    • 0353696
  • Serial Numbers (OUS)
    • 0349179
    • 0352344
    • 0352431
    • 0352626
    • 0353845
    • 0353883
    • 0353884
    • 0354625
    • 0355002
    • 0355181
Amount recalled
12 units

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

  • Nationwide

Why it was recalled

May contain small amounts of ethylene glycol residue

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new ConforMIS, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 2, 2016 · Data as of Sep 19, 6:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.