Reported May 21, 2014 · Terminated
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Blue Belt Technologies MN
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Blue Belt Technologies MN · 2905 Northwest Blvd Ste 40 · Plymouth, MN · 55441-2673
Is this the product you have?
NavioPFSTM SystemOrthopedic Sterotaxic Instrumentmodel #'s NPFS-02000NPFS-02010NPFS 02020
- Lot codes and dates
SN000090SN000091SN000092SN000187SN000200SN000204SN000226SN000231SN000232SN000246SN000247
- Amount recalled
- 11
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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