FDAFDA · Food and drugs·Recall number Z-2513-2025
Medshape Universal Joints, REF: DNE-9000-UJ
Published September 10, 2025 · Recall initiated: June 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Medshape, INC.
- Distributor
- 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.
- Lot
- UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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