Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version

FDA device recall Z-1133-2026 · posted 2026-01-20 · Open, Classified

Recall details

Recalling firm

MicroPort Orthopedics Inc.

Reason for recall

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

Action taken

On 12/19/2025, the firm email an "MicroPort Voluntary Recall - R25120001 HIPTURN Femoral Trial Head" communication to customers informing them that MicroPort was notified by the FDA that this device was not properly classified as a CLASS I device. MicroPort has decided not to pursue clearance of the device with a new FDA 510(k) submission and therefore has initiated field action to remove the device from the market. Customer are instructed to return the complete kits to MicroPort Orthopedics. For Questions - contact Bryan Callahan at 901-867-4594 or email address bryan.callahan@ortho.microport.com

Root cause

No Marketing Application

Status

Open, Classified

Product code

N/A

Quantity affected

91

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 Florid

Date initiated

2025-12-19

Date posted

2026-01-20

Location

Arlington, TN