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 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.
The orthopedic rotation tool's handle can untread from the shaft. This defect may prevent proper rotation of the implant, leading to potential surgical complications.
There are no specific reports of injuries related to this defect. However, the high hazard level indicates serious risks associated with its use.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Medicrea. Contact Medicrea International or your healthcare provider for further instructions.
For more details, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1039-2026. Alternatively, contact Medicrea International directly.
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