Reported Oct 28, 2015 · Terminated
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (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 iUni Unicondylar Knee Replacement System- iUNI G2
- Right Medial Catalog NumberM57220600220 (US) M5722INT0600220 (OUS)
- Lot codes and dates
- Serial Numbers (US)
03551460354541035526503547820355485035530303528210354413035375603510070354577035425003526760354571035383803532850347734035452003548410354148035330703554780354830035342703537290353683035388703514150354255035421903558070353995035294403533050352331
- Serial Numbers (OUS)
03479790349420035121803512790351682035168803517540351856035252303528680352918035307703534160353745035380503539330354141035418903541900354267035432503544210354427035456103546000354646035467803548100354850035533903553820355385
- Serial Numbers (US)
- Amount recalled
- 68 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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