Wright Medical Technology, Inc. recalls The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The pla…

Recall date

February 9, 2022

Source

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

Recall number

Z-0679-2022

FDA classification

Class II

Brand / firm

Wright Medical Technology, Inc.

Sold / distributed

International distribution in the countries of Japan and the United Kingdom.

Why it was recalled

Product was labelled with the incorrect manufacturing and distribution dates.

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

What was recalled

The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths