Vitality¿ Spinal Fixation System recalled over sterility concerns

Recall date

July 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer Biomet Spine Inc. recalls Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indi…

Recall number

Z-0866-2019

FDA classification

Class II

Brand / firm

Zimmer Biomet Spine Inc.

Sold / distributed

Distributed Nationwide: AL, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA and WI.**** International distribution: Australia and EMEA.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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