Medical device recalls Moderate risk

Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

Recall date
October 16, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0639-2024
FDA classification
Class II
Brand / firm
Zimmer Biomet Spine Inc.
Sold / distributed
US Nationwide distribution in the states of MN, NE.

Why it was recalled

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.

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 Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

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