Reported Mar 21, 2018 · Terminated
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- 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.pdfLE¿O-1100-40-000 REV D.pdf.pdfLE¿O-110030100_REV D.pdf.pdfLE¿O-110030110_REV D.pdf.pdfLE¿O-110030120_REV D.pdf.pdf
- Lot codes and dates
Lot # 855680285568038556804855680585833818556910855695186058498564487857243186103578527674
- Amount recalled
- 85
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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