Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1012-2018·Announced 2018-03-21

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
surgical-delay
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.

Same manufacturer · DePuy Orthopaedics, Inc.

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