Device recall
Z-0100-2015: GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS…
FDA device recall · Class II · Gyrus Medical, Inc
Key facts
| Recall number (Z-number) | Z-0100-2015 |
|---|---|
| Recall event | 69226 |
| Product | GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use… |
| Product code | GEI |
| Recalling firm | Gyrus Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2015 |
| 510(k) numbers | K031078, K031081 |
| FEI number | 3011050570 |
At a glance
- 1–9 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