MicroPort Orthopedics recalled 91 units of the HIPTURN Fem Head Trial 36mm Reusable device on December 19, 2025. The recall follows the lack of FDA premarket authorization for distribution in the United States. The affected devices were distributed across multiple states and several countries, posing a potential health risk to patients and healthcare providers.
Due to products not having FDA Premarket authorization to be distributed within the United States.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact MicroPort Orthopedics Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the HIPTURN Fem Head Trial 36mm Reusable, model number HTHT0036. It was distributed to various states including Texas, California, and Wisconsin, as well as internationally to countries like Belgium and Japan.
The devices lack FDA premarket authorization, meaning they have not undergone the necessary safety and effectiveness evaluations. This presents a significant risk to patient safety.
As of now, there have been no reported incidents or injuries related to this recall. However, the lack of FDA approval raises concerns about the safety of the device.
Patients and healthcare providers should stop using this device immediately. Follow the manufacturer's instructions for return and contact MicroPort Orthopedics Inc. for further guidance.
For more information, call MicroPort Orthopedics at 1-800-XXX-XXXX or visit their website. Additional details are available on the FDA's recall report page.
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