Skip to content

Brand Name: MicroPort recallZ-1133-2026 · MicroPort Orthopedics Inc. · initiated Dec 19, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MicroPort Orthopedics Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: No Marketing Application

What the company is doing

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 [email protected]

Recall details

Recall number
Z-1133-2026
Status
Open, Classified
Initiated by the company
Dec 19, 2025
Posted by the FDA
Jan 20, 2026
Recalling firm
MicroPort Orthopedics Inc.
Quantity
91
Product code
N/A
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.

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

Code information (models, lots, serial numbers)

Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page