Device recall
Z-1619-2010: Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems…
FDA device recall · Class II · I2s Micro Implantable Systems Llc
Key facts
| Recall number (Z-number) | Z-1619-2010 |
|---|---|
| Recall event | 55304 |
| Product | Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the… |
| Product code | GWL |
| Recalling firm | I2s Micro Implantable Systems Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 25, 2010 |
| 510(k) numbers | K042384 |
| FEI number | 3007323246 |
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