Class II

Medical Device Recall: Medshape Universal Joints, REF: DNE-9000-UJ

Medshape, INC. · June 2, 2025

Reason for Recall

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

849

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2513-2025

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.

Medshape, INC. Medical Device Recall: Medshape Universal Joints, REF: DNE-9000-UJ | SafeCheck