Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: ...
FDA Recall #Z-1133-2026 — Class II — December 19, 2025
Product 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 for Recall
Due to products not having FDA Premarket authorization to be distributed within the United States.
Recalling Firm
MicroPort Orthopedics Inc. — Arlington, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated