FDAFDA · Food and drugs·Recall number Z-1575-2014
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Published May 21, 2014 · Recall initiated: April 11, 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
Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Blue Belt Technologies MN
- Distributor
- USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
- Lot
- SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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