Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vitality¿ Spinal Fixation System. Spinal Interlaminal Recalled by Zimmer Biomet Spine Inc. Due to The Vitality Shear-off Set Screw is not threading...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Biomet Spine Inc. directly.
Affected Products
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.
Quantity: 16,429 devices (Thoracolumbosacral pedicle screw system,Spinal Interlaminal & Spinal Intervertebral Body, both appliances for fixation)
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer Biomet Spine Inc.
Zimmer Biomet Spine Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report