BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-1133-2026 · Reported January 28, 2026

    Enforcement

    Recall Number
    Z-1133-2026
    Event ID
    98220
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MicroPort Orthopedics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2026
    Initiation Date
    December 19, 2025
    Classification Date
    January 20, 2026
    Address
    5677 Airline Rd, Arlington, TN, 38002-9501, United States

    Description

    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

    Reason

    Due to products not having FDA Premarket authorization to be distributed within the United States.

    Code Info

    Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361

    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.

    Quantity

    91