Medicrea International: Device Recall

Recall #Z-1038-2026 · 10/29/2025

Class II: Risk

Recall Details

Recall Number: Z-1038-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medicrea International
Status: Ongoing
Date Initiated: 10/29/2025
Location: Rillieux La Pape, France
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 44 units

Reason for Recall

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

Product Description

Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Distribution Pattern

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

Other Recalls by Medicrea International

Class II: Risk 10/29/2025

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Class II: Risk 12/03/2024

Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

View all recalls by Medicrea International →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.