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Zimmer Biomet Spine Recalls
8 recalls on record · August 17, 2016 to January 10, 2024 · Medical Devices
Recalls by year
16
17
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 10, 2024Medical DevicesFDA
Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Hazard: Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
March 6, 2019Medical DevicesFDA
Zimmer Biomet Spine Inc. recalls Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation
Hazard: 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
March 6, 2019Medical DevicesFDA
Zimmer Biomet Spine Inc. recalls Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is ind
Hazard: 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
March 6, 2019Medical DevicesFDA
Zimmer Biomet Spine Inc. recalls Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indic
Hazard: 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
June 14, 2017Medical DevicesFDA
Zimmer Biomet Spine Inc. recalls Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number
Hazard: Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
April 5, 2017Medical DevicesFDA
Zimmer Biomet Spine, Inc recalls Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Sys
Hazard: Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.
August 17, 2016Medical DevicesFDA
Zimmer Biomet Spine, Inc recalls Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
Hazard: Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.
August 17, 2016Medical DevicesFDA
Zimmer Biomet Spine, Inc recalls Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Hazard: Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.