FDA recall, , Moderate risk
MicroPort HIPTURN Fem Head Trial 36mm Reusable
The Hipturn FEM Head Trial 36MM Reusable lacks FDA premarket authorization for U.S. distribution.
Summary by Recall Canary from the FDA notice
What happened
MicroPort Orthopedics Inc. of Arlington, Tennessee began a recall of the HIPTURN FEM Head Trial 36MM Reusable on December 19, 2025, because the product lacks FDA premarket authorization to be distributed within the United States. The recall was added to the FDA's Enforcement Report and classified on January 20, 2026, and in the FDA's weekly enforcement report on January 28, 2026.
The product was sent to distributors in multiple U.S. states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida, as well as to Belgium, Germany, France, Italy, United Kingdom, Japan, and China.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
HIPTURN FEM Head Trial 36MM Reusable
- Model number
- HTHT0036
- Lot code
- all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
Recall details
- Company began the recall
- Sold in
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.
- Company
- MicroPort Orthopedics Inc.Arlington, Tennessee
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98220
- Recall number
- Z-1133-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
