Medicrea recalled 44 units of its IB3D PL Instruments Set on October 29, 2025. The orthopedic rotation tool handle may untread from the shaft, causing it to fail during use. Healthcare providers and patients must stop using the device immediately.
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 Medicrea IB3D PL Instruments Set is a specialized tool used in orthopedic surgeries to assist in the placement of implants. Surgeons purchase this device for its precision and reliability during surgical procedures.
The defect in the orthopedic rotation tool handle may lead to failure during surgery, compromising patient safety and surgical outcomes. If the handle untreads, the implant cannot be rotated as intended, which is critical for proper placement.
This recall is not part of a broader industry pattern.
The recall poses a significant safety risk, potentially endangering patients during surgical procedures. It requires immediate action from healthcare providers to ensure patient safety.
The model number can typically be found on the device or its packaging.
Expect a refund or resolution within 4-6 weeks after returning the product.
Keep all correspondence related to the recall and take photos of the product and any issues.
The recall involves the Medicrea IB3D PL Instruments Set, Rx Only REF: SPS03174. It includes models Lot# 0001 through 0025. The instruments were distributed nationwide in states including TN, CA, MN, NC, TX, FL, OH, RI, and VA.
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