FDAJune 2, 2025device
Medshape Universal Joints, REF: DNE-9000-UJ
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
medshape
UPCs
00810028397101
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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