FDA DevicesClass II
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model...
Published: January 28, 2026Recall ID: Z-1133-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to products not having FDA Premarket authorization to be distributed within the United States.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Arlington |
| State | TN |
| Event id | 98220 |
| Address 1 | 5677 Airline Rd |
| Code info | Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361 |
| Postal code | 38002-9501 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 91 |
| Reason for recall | Due to products not having FDA Premarket authorization to be distributed within the United States. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20260120 |
Overview
- Recalling FirmMicroPort Orthopedics Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionThe 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.