Medical device recalls Moderate risk

NuVasive Specialized Orthopedics, Inc. recalls MAGEC 1 System

Recall date
June 25, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0528-2022
FDA classification
Class II
Brand / firm
NuVasive Specialized Orthopedics, Inc.
Sold / distributed
Worldwide

Why it was recalled

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

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

What was recalled

MAGEC 1 System

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