Device recall
Z-0591-2020: BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length…
FDA device recall · Class II · Brasseler USA I Lp
Key facts
| Recall number (Z-number) | Z-0591-2020 |
|---|---|
| Recall event | 84177 |
| Product | BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries. |
| Product code | GFF |
| Recalling firm | Brasseler USA I Lp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2020 |
| 510(k) numbers | K872475 |
| FEI number | 3004949275 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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