Blue Belt Technologies MN
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1943-2014 | Class II | Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis | June 4, 2014 |
| Z-1942-2014 | Class II | Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis | June 4, 2014 |
| Z-1575-2014 | Class II | NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020. | April 11, 2014 |
| Z-1995-2013 | Class II | Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usa | July 19, 2013 |