In2Bones, SAS recalls NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular…

Recall date

December 19, 2016

Source

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

Recall number

Z-0954-2017

FDA classification

Class II

Brand / firm

In2Bones, SAS

Sold / distributed

Worldwide Distribution - US TN only and Internationally to France and Switzerland

Why it was recalled

Dimensional non-conformity of the thread on the screw head.

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

What was recalled

NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius