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TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4… recallZ-0118-2020 · TriMed Inc. · initiated Aug 24, 2018

Class II Terminated All recalls posted in October 2019

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from TriMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0118-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 24, 2018
Posted by the FDA
Oct 10, 2019
Recalling firm
TriMed Inc.
Quantity
5 devices
Product code
HRS
FDA submissions
K951302
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.

Product description

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.

Code information (models, lots, serial numbers)

Lot numbers 28884, 28885, 28886, and 28887

Other devices under the same FDA submission

4 devices cleared under K951302 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page