FDA-Device2019-10-16Class II
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.
TriMed Inc.
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.
Sold states
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.
Affected count
5 devices
Manufactured in
27533 Avenue Hopkins, N/A, Santa Clarita, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2020Don't want to check this manually?
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