Recall Z-1575-2014— Blue Belt Technologies MN
Class II · Terminated
Class II FDA medical device recall by Blue Belt Technologies MN, initiated 2014-04-11, terminated 2014-06-10. It names one FDA 510(k) clearance: K121936. Product: NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.. Reason: 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..
- Recalling firm
- Blue Belt Technologies MN
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-11
- Terminated
- 2014-06-10
- Firm location
- Plymouth, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.