Class 2 Device Recall TriMed Hex Driver 1.2

• Date Initiated by Firm: September 28, 2018
• Create Date: November 12, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0357-2020
• Recall Event ID: 83820
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
• Code Information: Lot numbers 91500604 and 91600017
• 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: 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: 467 hex drivers
• 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.