Device recall
Z-1327-2021: Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic…
FDA device recall · Class II · Stryker Sustainability Solutions
Key facts
| Recall number (Z-number) | Z-1327-2021 |
|---|---|
| Recall event | 87434 |
| Product | Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to… |
| Product code | NLQ |
| Recalling firm | Stryker Sustainability Solutions |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161693 |
| FEI number | 3009350690 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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