Z-1133-2026Class II

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

Name: Z-1133-2026 Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036...
Creator: MicroPort Orthopedics Inc.
Published: 2025-12-19
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2025-12-19 / Open, Classified

FDA source

MicroPort Orthopedics Inc. began a recall of Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM... on 2025-12-19. FDA classified it as Class II and gives the reason as "Due to products not having FDA Premarket authorization to be distributed within the United States". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1133-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-01-20
Recalling firm: Microport Orthopedics Inc.
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
Product code: N/A
Reason for recall: Due to products not having FDA Premarket authorization to be distributed within the United States.
FDA root cause: No Marketing Application
Action: 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]
Quantity in commerce: 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 Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.
Product codes and lots: Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1133-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1133-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-20

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)