Drug recall
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal…
FDA recall event 80541 · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Event ID | 80541 |
|---|---|
| Recall numbers | Z-2603-2018 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Product type | Devices |
| Products | Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier… |
| Initiation date | Jul 9, 2018 |
| Report date | Aug 15, 2018 |
| Termination date | May 7, 2021 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 1000477302 |
At a glance
- 1–9 Products in this recall
- 10–99 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: