Drug recall
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA recall event 78790 · Class II · Medtronic Sofamor Danek USA Inc
Key facts
| Event ID | 78790 |
|---|---|
| Recall numbers | Z-0352-2018 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Product type | Devices |
| Products | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument. |
| Initiation date | Dec 6, 2017 |
| Report date | Jan 24, 2018 |
| Termination date | Nov 4, 2019 |
| 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: