# FDA recall Z-1012-2018

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2017-11-28.

## 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, LE¿O-110030120_REV D.pdf.pdf

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1012-2018
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-28
- **Report date:** 2018-03-21
- **Termination date:** 2020-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2018

## Citation

> AI Analytics. FDA recall Z-1012-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-1012-2018. Source: US FDA. Licensed CC0.

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