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 IB3D Universal Implant Inserter is used in orthopedic procedures to assist with the placement of implants. Surgeons rely on this tool to rotate implants accurately during operations, making it essential for successful outcomes.
The handle of the inserter may untread from the shaft, leading to a failure in the device's ability to rotate implants as intended. This can create serious complications during surgical procedures.
This recall is not part of a broader industry pattern.
The recall affects the safety and reliability of surgical procedures involving implants. Patients and healthcare providers may experience delays in surgeries while seeking alternative tools.
Model numbers and lot information can typically be found on the device packaging or the device itself.
Expect a refund or replacement processing time of about 4 to 6 weeks.
Keep records of your purchase, any correspondence with Medicrea, and photos of the device as evidence.
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.
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