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 HIPTURN Fem Head Trial device is used in orthopedic procedures to assist in surgical planning and execution. Healthcare providers utilize such devices to ensure precision during surgeries.
The lack of FDA premarket authorization raises serious concerns about the safety and efficacy of the device. Without proper evaluation, there is no assurance of its performance or potential risks to patients.
This recall is not part of a broader industry pattern.
This recall places a significant burden on healthcare providers who must stop using the device, potentially disrupting surgical schedules and leading to delays in treatment.
The lot codes and model number can typically be found on the packaging or the device itself.
Expect a processing time of 4-6 weeks for any refund or replacement from MicroPort Orthopedics.
Keep records of your purchase, any communication from the manufacturer, and details regarding the device for your records.
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.
Not sure what to do next? Our guide walks you through the process step by step.
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