Device recall
Z-0388-2017: SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD…
FDA device recall · Class II · Akita Sumitomo Bakelite Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0388-2017 |
|---|---|
| Recall event | 75388 |
| Product | SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical… |
| Product code | KNS |
| Recalling firm | Akita Sumitomo Bakelite Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 10, 2016 |
| 510(k) numbers | K152771 |
| FEI number | 3002806337 |
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