FDAFDA · Food and drugs·Recall number Z-0581-2015
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Published December 17, 2014 · Recall initiated: November 19, 2014
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 serial number of tibial inserts packaged in tray may result in inserts not fitting
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 to IN.
- Lot
- Serial Number: 0340552
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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