FDA-Device2026-01-28Class IIMISBRANDING
MicroPort HIPTURN FEM HEAD TRIAL 36MM hip implant recalled for lacking FDA authorization
Stop using MicroPort HIPTURN hip implant trial
MicroPort Orthopedics distributed a hip implant trial component (HIPTURN FEM HEAD TRIAL 36MM) in the United States without FDA premarket authorization. The company sent approximately 91 units to distributors across multiple states. No injuries have been reported.
- If you received this product as a distributor or healthcare facility, contact MicroPort Orthopedics immediately and stop using or distributing it.
- If you are a patient who may have received this implant, contact your surgeon or healthcare provider to discuss your specific situation.
- Return the product to MicroPort Orthopedics or your distributor as instructed.
Hazard
Due to products not having FDA Premarket authorization to be distributed within the United States.
Sold states
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.
Affected count
91
Manufactured in
5677 Airline Rd, Arlington, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2026Don't want to check this manually?
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