FDAFDA · Food and drugs·Recall number Z-0140-2016
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
Published October 28, 2015 · Recall initiated: August 31, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
May contain small amounts of ethylene glycol residue
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- ConforMIS, Inc.
- Distributor
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Lot
- Serial Numbers (US): 0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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