Reported Oct 28, 2015 · Terminated
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210…
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 Unicondylar Knee Replacement System iUNI G2
- Left Medial Catalog NumberM57220600210(US) M5722INT0600210 (OUS)
- Lot codes and dates
- Serial Numbers (US)
03539010354506035422003555500355016035078903541110354321035293903531540353812035482803545760354180035558803550640353912035123703519830354434035337403516420352751035555703537570353944035421803538460353688035511003524830345608035377103533063054517
- Serial Numbers (OUS)
034870503495920351522035161603527000352750035282703528400352999035321003532250353263035342003535140353515035357703537140353791035382203539180353921035416303542080354284035429203544390354507035450903546050354771035477303547920355178035518803552020355227
- Serial Numbers (US)
- Amount recalled
- 71 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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