Blue Belt Technologies Recalls Navio PFS Orthopedic Sterotaxic Instrument
Blue Belt Technologies is voluntarily recalling 11 Navio PFS systems used in orthopedic knee surgery due to a potential electronic module defect that could cause latent failure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential defect that could result in latent failure during surgery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Blue Belt Technologies is conducting a voluntary recall of 11 units of the Navio PFS System, an orthopedic sterotaxic instrument used during orthopedic knee surgery. The affected models are NPFS-02000, NPFS-02010, and NPFS 02020.
The recall is being issued because one of the electronic modules inside the computer cart assembly may have a defect in one of its components. This defect could result in a latent failure of the system. The affected units were distributed in the United States (California, Pennsylvania, Ohio, Texas) and internationally (Belgium, Scotland, United Kingdom).
Healthcare facilities and consumers should stop using the affected Navio PFS systems immediately and contact Blue Belt Technologies for further instructions on the recall process.
The recalled product
- Product
- NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
- Manufacturer
- Blue Belt Technologies MN
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- SN000090
- SN000091
- SN000092
- SN000187
- SN000200
- SN000204
- SN000226
- SN000231
- SN000232
- SN000246
- SN000247
Distribution
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