8 results
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76ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine, Inc·August 17, 2016
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
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019
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
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine, Inc·April 5, 2017
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.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine Inc.·March 6, 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
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine, Inc·August 17, 2016
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
FDA Enforcement
Class II
·Terminated·Zimmer Biomet Spine Inc.·June 14, 2017
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
FDA Enforcement
Class II
·Ongoing·Zimmer Biomet Spine Inc.·January 10, 2024