Home / Recalls / Medical Devices
Medshape, INC. recalls Medshape Universal Joints, REF: DNE-9000-UJ
Recalled September 10, 2025 · FDA recall Z-2513-2025 · Medshape
Hazard
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. · FDA Class II
Units
849
Sold at
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.
Description
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.
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Manufacturer(s)
Medshape, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →