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FDANovember 28, 2017device

The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf, LE¿O-110030120_REV...

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

The hazard

The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

Recall history

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

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