FDA recall Z-2513-2025

Medshape, INC. · Class II · device

Product

Medshape Universal Joints, REF: DNE-9000-UJ

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.

Key facts

Status
Ongoing
Initiation date
2025-06-02
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2513-2025