Zimmer Biomet Spine, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0639-2024 | Class II | Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixati | October 16, 2023 |
| Z-0866-2019 | Class II | Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle scr | July 30, 2018 |
| Z-0867-2019 | Class II | Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle s | July 30, 2018 |
| Z-0868-2019 | Class II | Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Ped | July 30, 2018 |
| Z-2318-2017 | Class II | Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 | May 10, 2017 |
| Z-1691-2017 | Class II | Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and Alti | March 16, 2017 |
| Z-2398-2016 | Class II | Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. | June 30, 2016 |
| Z-2397-2016 | Class II | Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. | June 30, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212023 | Virage Navigation System | August 27, 2021 |
| K203218 | CaP Spheres Pellet Pack | May 4, 2021 |
| K210275 | Polaris Spinal System | April 2, 2021 |
| K203507 | Vitality® Spinal Fixation System | January 28, 2021 |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw | October 8, 2020 |
| K191722 | Vital Navigation System | December 2, 2019 |
| K192133 | Zimmer Biomet Universal Navigation System | October 29, 2019 |
| K190556 | Zimmer Biomet Universal Navigation System | October 24, 2019 |
| K183550 | Vitality® Spinal Fixation System | April 8, 2019 |
| K181096 | Avenue P Cage System | January 15, 2019 |
| K180227 | Polaris Spinal Growth System | March 15, 2018 |
| K171495 | Zyston Strut Open Titanium Spacer System | February 12, 2018 |
| K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | September 27, 2017 |
| K171907 | Vitality® Spinal Fixation System | July 14, 2017 |
| K163543 | Biomet Fusion System | February 28, 2017 |