FDAFDA · Food and drugs·Recall number Z-1070-2016
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Published March 16, 2016 · Recall initiated: January 28, 2016
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
Incorrect femoral component distributed
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
- KY
- Lot
- Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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