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U.S. Department of Health and Human Services

Class 2 Device Recall TriMed Countersink

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  Class 2 Device Recall TriMed Countersink see related information
Date Initiated by Firm September 28, 2018
Create Date November 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-0355-2020
Recall Event ID 83820
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Code Information Lot number 91401455
Recalling Firm/
Manufacturer		 TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
For Additional Information Contact Mr. David Medoff
661-255-7406
Manufacturer Reason
for Recall		 The epoxy on Apex manufactured epoxy-coated instruments can pop off.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The recalling firm issued letters via email on 9/28/2018 explaining the reason for recall and requesting consignees to identify potentially-affected product and quarantine it until a TriMed representative is able to conduct an inspection.
Quantity in Commerce 99 instruments
Distribution Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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