Z-1133-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 28, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 91
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.
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.
Code Information
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361