TriMed Dorsal Wrist Hook Plate recalled over sterility concerns

Recall date

August 24, 2018

Source

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

Official notice title

TriMed Inc. recalls TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing vary…

Recall number

Z-0118-2020

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.

Why it was recalled

Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

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

What was recalled

TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.