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TriMed Inc. recalls TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varyi
Recalled October 16, 2019 · FDA recall Z-0118-2020 · TriMed
Hazard
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. · FDA Class II
Units
5 devices
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
TriMed Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →