MicroPort Orthopedics Inc.: Device Recall

Recall #Z-1133-2026 · 12/19/2025

Class II: Risk

Recall Details

Recall Number
Z-1133-2026
Classification
Class II
Product Type
Device
Recalling Firm
MicroPort Orthopedics Inc.
Status
Ongoing
Date Initiated
12/19/2025
Location
Arlington, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
91

Reason for Recall

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

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

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.