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FDANovember 3, 2025device

Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Labeling contains claims that are not consistently present.

What to do

FDA enforcement status: Ongoing

Brands named

orthofix u sorthofix

UPCs

1825720003079818257200146550

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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