FDAHealthJune 2, 2025
Medshape, INC. — Medshape Universal Joints, REF: DNE-9000-UJ
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 2, 2025
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.
What's affected?
- Product
- Medshape Universal Joints, REF: DNE-9000-UJ
- Brand
- Medshape, INC.
- Lot code
- :
Additional details
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 849.
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