Skip to content
Recall Observatory FDA recall evidence

Device product

Medshape Universal Joints, REF: DNE-9000-UJ

Z-2513-2025

June 02, 2025

Class II

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

    reason.no_named_rule · v1.0.0

    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.