Medshape, INC. recalls Medshape Universal Joints, REF: DNE-9000-UJ

Recall date

June 2, 2025

Source

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

Recall number

Z-2513-2025

FDA classification

Class II

Brand / firm

Medshape, INC.

Sold / distributed

US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA.

Why it was recalled

Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

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

What was recalled

Medshape Universal Joints, REF: DNE-9000-UJ