Device recall
Z-1938-2018: Disposable Drill Kit which includes two drill bits, two drill stops, and two…
FDA device recall · Class II · Ad-Tech Medical Instrument Corporation
Key facts
| Recall number (Z-number) | Z-1938-2018 |
|---|---|
| Recall event | 80002 |
| Product | Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame. |
| Product code | LXH |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 12, 2018 |
| FEI number | 2183456 |
At a glance
- None 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