Recall Z-1133-2026— MicroPort Orthopedics Inc.

Name: FDA recall Z-1133-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Class II · Ongoing

Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2025-12-19. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to products not having FDA Premarket authorization to be distributed within the United States..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-19
Firm location: Arlington, TN, United States

Product description

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 for recall

Due to products not having FDA Premarket authorization to be distributed within the United States.

Data sourced from openFDA. This site is unofficial and independent of the FDA.