Device product
Medshape Universal Joints, REF: DNE-9000-UJ
Z-2513-2025
Product summary
- Firm
- Medshape, INC.
- Event
- Event 97064
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 849
- Official record key
device-enforcement:Z-2513-2025
Official wording
Reason: 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.
Code information: UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.