Class II

Medical Device Recall: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Medicrea International · October 29, 2025

Reason for Recall

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Distribution

US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

States Affected

NATIONWIDE

Quantity Affected

44 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1038-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Medicrea International Medical Device Recall: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 | SafeCheck