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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, 4Holesee related information
Date Initiated by FirmAugust 24, 2018
Date PostedOctober 10, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0118-2020
Recall Event ID 83563
510(K)NumberK951302 
Product Classification Plate, fixation, bone - Product Code HRS
ProductTriMed 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
FEI Number 3001236812
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information ContactMr. David Medoff
661-255-7406
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
ActionThe 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 Commerce5 devices
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = HRS
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