Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The GLOBAL UNITE Platform Shoulder System is intended for cemented Recalled by DePuy Orthopaedics, Inc. Due to The screw in specific lots of the GLOBAL...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Orthopaedics, Inc. directly.
Affected Products
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 D.pdf.pdf
Quantity: 85
Why Was This Recalled?
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.
Where Was This Sold?
Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates.
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report