Device recall
Z-0621-2018: ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT…
FDA device recall · Class II · Aesculap Implant Systems LLC
Key facts
| Recall number (Z-number) | Z-0621-2018 |
|---|---|
| Recall event | 79068 |
| Product | ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5… |
| Product code | HBE |
| Recalling firm | Aesculap Implant Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2019 |
| FEI number | 2916714 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database