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Class 2 Device Recall TriMed Dorsal Wrist Hook Plate, Dorsal, 4Hole |
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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
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Product Classification |
Plate, fixation, bone - Product Code HRS
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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/ Manufacturer |
TriMed Inc. 27533 Avenue Hopkins Santa Clarita CA 91355-3910
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For Additional Information Contact |
Mr. David Medoff 661-255-7406
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HRS and Original Applicant = MEDPAC
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