DePuy Global Unite Shoulder System Recall Due to Inverted Screw Assembly
DePuy Orthopaedics is recalling 85 units of the Global Unite Platform Shoulder System because an inverted screw may cause the humeral stem to sit proud, potentially delaying surgery.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a manufacturing defect that may cause surgical delays, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 85 units of the GLOBAL UNITE Platform Shoulder System. The recall involves specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body. The affected devices are intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures.
The recall was initiated because the screw in the affected lots was inverted during assembly to the body. This manufacturing error causes the humeral stem to sit proud, which may result in surgical delays. The distribution level extends to the company's US distributors, sales offices, and medical facilities that may have used, purchased, or received the devices. Approximately 53 units were distributed to the firm's international affiliates.
Medical facilities and distributors should identify the affected units by checking the lot numbers listed in the recall notice. Patients who have already had surgery with these devices should contact their healthcare provider if they have concerns. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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,
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 85
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Lot # 8556802
- 8556803
- 8556804
- 8556805
- 8583381
- 8556910
- 8556951
- 8605849
- 8564487
- 8572431
- 8610357
- 8527674.
Distribution
Distribution scope not specified by the agency.
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