Drug recall
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or…
FDA recall event 79257 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 79257 |
|---|---|
| Recall numbers | Z-1012-2018 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 28, 2017 |
| Report date | Mar 21, 2018 |
| Termination date | Mar 27, 2020 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1818910 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: