Medical device recalls Moderate risk

Biomet Spine, LLC recalls MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate…

Recall date
September 29, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0203-2016
FDA classification
Class II
Brand / firm
Biomet Spine, LLC
Sold / distributed
US Distribution to the states of : NY, MO, and FL

Why it was recalled

The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.

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

What was recalled

MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.

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