Zimmer Biomet Spine, Inc.
Zimmer Biomet Spine, Inc. holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2021, with 8 FDA device recalls on record.
Top product codes for Zimmer Biomet Spine, Inc.
FDA recalls by Zimmer Biomet Spine, Inc.
- Z-0639-2024 — Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
- Z-0866-2019 — Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications
- Z-0867-2019 — Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.
- Z-0868-2019 — Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications
- Z-2318-2017 — Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
- Z-1691-2017 — Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only
- Z-2398-2016 — Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
- Z-2397-2016 — Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Zimmer Biomet Spine, Inc.
- K212023 — Virage Navigation System
- K203218 — CaP Spheres Pellet Pack
- K210275 — Polaris Spinal System
- K203507 — Vitality® Spinal Fixation System
- K202309 — Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
- K191722 — Vital Navigation System
- K192133 — Zimmer Biomet Universal Navigation System
- K190556 — Zimmer Biomet Universal Navigation System
- K183550 — Vitality® Spinal Fixation System
- K181096 — Avenue P Cage System
- K180227 — Polaris Spinal Growth System
- K171495 — Zyston Strut Open Titanium Spacer System
- K172275 — Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
- K171907 — Vitality® Spinal Fixation System
- K163543 — Biomet Fusion System
Data sourced from openFDA. This site is unofficial and independent of the FDA.