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.

Reason: 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.

Code information: Lot numbers 28884, 28885, 28886, and 28887

Distribution pattern: 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.