FDAFDA · Food and drugs·Recall number Z-0138-2016
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (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): 0355239 0355108 0355474 0354538 Serial Numbers (OUS): 0353919 0354845 0354849
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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