Drug recall
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared…
FDA recall event 79072 · Class II · DePuy Orthopaedics, Inc.
Key facts
| Event ID | 79072 |
|---|---|
| Recall numbers | Z-0848-2018, Z-0849-2018 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Product type | Devices |
| Products | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine., Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for Intra-operative breakage of driver tips |
| Initiation date | Jul 26, 2017 |
| Report date | Mar 14, 2018 |
| Termination date | Apr 3, 2019 |
| City | Raynham |
| State | MA |
| Country | United States |
| FEI number | 1219655 |
At a glance
- 1–9 Products in this recall
- 1–9 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: