FDA-Device2025-09-10Class II
Medshape Universal Joints, REF: DNE-9000-UJ
Medshape, INC.
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.
Sold states
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.
Affected count
849
Manufactured in
1575 Northside Dr Nw Ste 440, N/A, Atlanta, GA, United States
Products
Medshape Universal Joints, REF: DNE-9000-UJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2513-2025Don't want to check this manually?
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