Z-0118-2020Class II

TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package...

Name: Z-0118-2020 TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package...
Creator: TriMed Inc.
Published: 2018-08-24
License: https://open.fda.gov/license/

Trimed Inc / initiated 2018-08-24 / Terminated / root cause: design

FDA source

TriMed Inc. began a recall of 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... on 2018-08-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0118-2020
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Posted: 2019-10-10
Terminated: 2021-04-28
Recalling firm: Trimed Inc
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.
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 5 devices
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 codes and lots: Lot numbers 28884, 28885, 28886, and 28887

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0118-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-10

Product code HRS

K951302Class IISmall Fragment Plates and ScrewsMedpac / cleared 1995-05-05

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)