Device recall
Z-2049-2018: HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length /…
FDA device recall · Class II · Ethicon Endo-Surgery Inc
Key facts
| Recall number (Z-number) | Z-2049-2018 |
|---|---|
| Recall event | 80066 |
| Product | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The… |
| Product code | LFL |
| Recalling firm | Ethicon Endo-Surgery Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2019 |
| 510(k) numbers | K121550 |
| FEI number | 1527736 |
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