Class 2 Device Recall MicroPort

• Date Initiated by Firm: December 19, 2025
• Date Posted: January 20, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1133-2026
• Recall Event ID: 98220
• Product Classification: unknown device name - Product Code N/A
• Product: Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
• Code Information: Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
• Recalling Firm/ Manufacturer: MicroPort Orthopedics Inc.; 5677 Airline Rd; Arlington TN 38002-9501
• For Additional Information Contact: Trey Haire; +1-901-8674314
• Manufacturer Reason for Recall: Due to products not having FDA Premarket authorization to be distributed within the United States.
• FDA Determined Cause: No Marketing Application
• Action: On 12/19/2025, the firm email an "MicroPort Voluntary Recall - R25120001 HIPTURN Femoral Trial Head" communication to customers informing them that MicroPort was notified by the FDA that this device was not properly classified as a CLASS I device. MicroPort has decided not to pursue clearance of the device with a new FDA 510(k) submission and therefore has initiated field action to remove the device from the market. Customer are instructed to return the complete kits to MicroPort Orthopedics. For Questions - contact Bryan Callahan at 901-867-4594 or email address bryan.callahan@ortho.microport.com
• Quantity in Commerce: 91
• Distribution: The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.

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.