Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

Recall date

October 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1039-2026

FDA classification

Class II

Brand / firm

Medicrea International

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174