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U.S. Department of Health and Human Services

Class 2 Device Recall TriMed Dorsal Wrist Hook Plate, Dorsal, 4Hole

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  Class 2 Device Recall TriMed Dorsal Wrist Hook Plate, Dorsal, 4Hole see related information
Date Initiated by Firm August 24, 2018
Date Posted October 10, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0118-2020
Recall Event ID 83563
510(K)Number K951302  
Product Classification Plate, fixation, bone - Product Code HRS
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.
Code Information Lot numbers 28884, 28885, 28886, and 28887
Recalling Firm/
TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information Contact Mr. David Medoff
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = MEDPAC