Medshape Universal Joints, REF: DNE-9000-UJ
FDA Recall #Z-2513-2025 — Class II — June 2, 2025
Product Description
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.
Recalling Firm
Medshape, INC. — Atlanta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
849
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.
Code Information
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated