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U.S. Department of Health and Human Services

Class 2 Device Recall Trexo Home and Trexo Plus

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  Class 2 Device Recall Trexo Home and Trexo Plus see related information
Date Initiated by Firm May 31, 2023
Date Posted July 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-2236-2023
Recall Event ID 92563
Product Classification System, isokinetic testing and evaluation - Product Code IKK
Product Trexo Device
Code Information All devices.
Recalling Firm/
Manufacturer		 Trexo Robotics Holdings Inc.
6705 Millcreek Dr Unit 3
Mississauga Canada
Manufacturer Reason
for Recall		 Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
FDA Determined
Cause 2		 Device Design
Action The firm distributed recall notification to customers by email on 5/31/2023. This notification asks that customers not expose the device to rain or spilled liquids, not store the device outdoors, wear pants to cover exposed skin to minimize the effect of hot surfaces, and if experiencing any electrical interference or difficulty operating another device in the vicinity of a Trexo device move away and and/or turn off the Trexo Device. Affected devices will be subject to a correction which will be carried out by technician; technician appointments will be scheduled once customers reply to the recall notification. Customers with any questions or concerns may contact the firm at correction@trexorobotics.com. Customers are asked to return the provided response form.
Quantity in Commerce 357 units
Distribution Worldwide distribution - US Nationwide and the countries of the Argentina, Australia, Brazil, Canada, China, Croatia, Czech Republic, England, Germany, India, Kuwait, Mexico, Poland, Qatar, Republic of Cyprus, Serbia, Singapore, Slovakia, Spain, United Arab Emirates, and Yemen.
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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