FDA Device recall Z-0118-2020
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonster…
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonster… by Trimed, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-24 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Trimed |
| Distribution | CA, FL, MD, TX, WA |
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
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.
Identifiers
| code_info | Lot numbers 28884, 28885, 28886, and 28887 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2020%22
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