Recall Z-0118-2020— TriMed Inc.

Name: FDA recall Z-0118-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-24

Class II · Terminated

Class II FDA medical device recall by TriMed Inc., initiated 2018-08-24, terminated 2021-04-28. It names one FDA 510(k) clearance: K951302. 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..

Recalling firm: TriMed Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Terminated: 2021-04-28
Firm location: Santa Clarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K951302 — SMALL FRAGMENT PLATES AND SCREWSMedpac·cleared 1995-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.