Drug recall
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in…
FDA recall event 79115 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 79115 |
|---|---|
| Recall numbers | Z-0833-2018, Z-0834-2018 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional…, DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay. |
| Initiation date | Aug 31, 2017 |
| Report date | Mar 7, 2018 |
| Termination date | Mar 12, 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: