Drug recall
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1)…
FDA recall event 91780 · Class II · Elekta Instrument AB
Key facts
| Event ID | 91780 |
|---|---|
| Recall numbers | Z-1309-2023 |
| Recalling firm | Elekta Instrument AB |
| Product type | Devices |
| Products | Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The incorrect IFU was distributed with the devices. |
| Initiation date | Mar 1, 2023 |
| Report date | Apr 5, 2023 |
| City | Stockholm |
| Country | Sweden |
| FEI number | 3002806883 |
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: