MicroPort Orthopedics Inc.: Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product De
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- MicroPort Orthopedics Inc.
- 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
- Reason / hazard
- Due to products not having FDA Premarket authorization to be distributed within the United States.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-19
- Code info
- Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
- Product quantity
- 91
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Arlington
- State
- TN
- Country
- United States
- Event id
- 98220
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