Medicrea recalled 44 units of its IB3D Universal Implant Inserter on October 29, 2025. The device's handle may untread from the shaft, preventing proper rotation of implants. The recall affects states including TN, CA, and TX.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medicrea International or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the IB3D Universal Implant Inserter, REF: A24000000. It was distributed nationwide in states such as Tennessee, California, Minnesota, and Texas. The model numbers include Lot# 21J0410, 21J0414, 21J0418, and others.
The orthopedic rotation tool's handle may untread from the shaft. This defect could compromise the ability to rotate the implant during procedures, posing risks to patient safety.
No specific injuries or incidents have been reported related to this recall. The risk is classified as high due to the potential for malfunctions during surgical procedures.
Patients and healthcare providers should stop using the device immediately. Follow the instructions provided by the manufacturer for returning the product.
Contact Medicrea International or your healthcare provider for further instructions. More details are available on the FDA's website.
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