FDA Medical devices recall ·
MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model recall
- Recall number
- Z-1133-2026
- Date
- (initiated December 19, 2025)
- Company / brand
- MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 91
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to products not having FDA Premarket authorization to be distributed within the United States.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
Distribution
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: California Colorado Florida Georgia Illinois Kansas Maryland Michigan Missouri Tennessee Texas Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1133-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.