Zimmer Biomet Spine, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 15
- FDA recalls
- 81 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Zimmer Biomet Spine, Inc. makes
Zimmer Biomet Spine, Inc. manufactures spinal fixation systems, including pedicle screws, plates, and cages for surgical fusion, such as the Polaris Spinal System, Vitality® Spinal Fixation System, and Epic Anterior Thoracolumbar Plate System. Their portfolio also includes navigation tools like the Virage Navigation System and Zimmer Biomet Universal Navigation System for precision surgical guidance. Additional offerings include growth modulation devices like the Polaris Spinal Growth System and bone graft substitutes, such as the CaP Spheres Pellet Pack.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. Their products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 15 devicesFDA recalls
FDA recall records list 8 recalls initiated by Zimmer Biomet Spine, Inc., the earliest on 2016-06-30 and the most recent on 2023-10-16. By recorded status: 1 ongoing and 7 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 3
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 16 Oct 2023 Z-0639-2024 Class II Ongoing 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.
2018
- 30 Jul 2018 Z-0866-2019 Class II Terminated 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
Full distribution text
- 30 Jul 2018 Z-0867-2019 Class II Terminated 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
Full distribution text
- 30 Jul 2018 Z-0868-2019 Class II Terminated 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
Full distribution text
- 30 Jul 2018 Z-0866-2019 Class II Terminated 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
2017
- 10 May 2017 Z-2318-2017 Class II Terminated 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.
- 16 Mar 2017 Z-1691-2017 Class II Terminated 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.
2016
- 30 Jun 2016 Z-2397-2016 Class II Terminated 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.
- 30 Jun 2016 Z-2398-2016 Class II Terminated 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.
Frequently asked questions
How many devices does Zimmer Biomet Spine, Inc. have in the registry?
The registry currently lists 15 devices for Zimmer Biomet Spine, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zimmer Biomet Spine, Inc.'s devices?
Among its 15 most recently registered devices, Zimmer Biomet Spine, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Zimmer Biomet Spine, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Zimmer Biomet Spine, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Zimmer Biomet Spine, Inc.?
FDA recall records list 8 recalls initiated by Zimmer Biomet Spine, Inc., the most recent initiated on 2023-10-16. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Zimmer Biomet Spine, Inc. in the registry?
The most recently registered devices listed for Zimmer Biomet Spine, Inc. include Polaris Spinal System, CaP Spheres Pellet Pack, Vitality® Spinal Fixation System and Virage Navigation System.