Aesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the…

Recall date

July 15, 2022

Source

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

Recall number

Z-1638-2022

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

GA, TX

Why it was recalled

Potential for the incorrect screw to be included in the package.

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

What was recalled

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014