CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report
NavioPFSTM System, Orthopedic Sterotaxic Instrument recalled
Blue Belt Technologies MN is recalling NavioPFSTM System, Orthopedic Sterotaxic Instrument, distributed in California, Ohio, Pennsylvania, Texas. The recall was initiated on 11 Apr 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1575-2014
- FDA event ID
- 68015
- Recalling firm
- Blue Belt Technologies MN, Plymouth, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2014
- FDA classified
- 9 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 11 Apr 2014 | Recall initiated by company | |
| 9 May 2014 | Classified by FDA | +28 days |
| 21 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Where it was distributed
USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
Questions about this recall
Why was it 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.
Which lots are affected?
SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247
Where was it sold?
USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Blue Belt Technologies MN
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|---|---|---|---|---|---|
| Device | CLASS II | Stride Femoral Component Size 2, Pfsi recalled | Blue Belt Technologies MN | Labeling Errors | Nationwide |
| Device | CLASS II | Stride Femoral Component Size 2, Pfsi recalled | Blue Belt Technologies MN | Labeling Errors | Nationwide |
| Device | CLASS II | Blue Belt Technologies, Inc. Monitor Drape recalled | Blue Belt Technologies MN | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |