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.
- Company
- Trimed Inc.
- Recall Initiated
- August 24, 2018
- Posted
- October 10, 2019
- Terminated
- April 28, 2021
- Recall Number
- Z-0118-2020
- Quantity
- 5 devices
- Firm Location
- 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.
Lot / Code Info
Lot numbers 28884, 28885, 28886, and 28887
Root Cause
Device Design
Action Taken
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.
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