FDA recall Z-0118-2020

TriMed Inc. · Class II · 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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2018-08-24
Report date
2019-10-16
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2020