Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE ... recall (MicroPort Orthopedics Inc.)
Medical deviceClass IIOngoing
Summary: MicroPort Orthopedics Inc. is recalling 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: Due to products not having FDA Premarket authorization to be distributed within the United States.
What is being recalled
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
Why
Due to products not having FDA Premarket authorization to be distributed within the United States.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: California, Colorado, Florida, Georgia, Illinois, Kansas, Maryland, Michigan, Missouri, Tennessee, Texas, Washington, Wisconsin)
How to tell if yours is affected
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1133-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 19, 2025 |
| Reported | January 28, 2026 |
| Company | MicroPort Orthopedics Inc. |
| Company location | Arlington, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 91 |
More recalls from MicroPort Orthopedics Inc. · all medical device recalls · recalls from December 2025