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.

Recall Insight

This FDA Devices action (record #Z-0118-2020) was formally reported on October 16, 2019, with the manufacturer initiating the action on August 24, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. TriMed Inc. is listed as the recalling firm, operating out of Santa Clarita, CA. Federal records indicate 5 devices units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.