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.
FDA Recall Z-0118-2020 · Posted 2019-10-10
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Recalling FirmTriMed Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2018-08-24
Date Terminated2021-04-28
Product Quantity5 devices
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.
Firm Action
The recalling firm issued letters via email on 8/24/2018 informing the distributor of the medical facility of the issue. The distributor is then responsible for notifying the medical facility to whom the device is invoiced.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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