Device recall
Z-1611-2010: 4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray…
FDA device recall · Class II · Blackstone Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1611-2010 |
|---|---|
| Recall event | 55508 |
| Product | 4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw. |
| Product code | HWX |
| Recalling firm | Blackstone Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2010 |
| FEI number | 3001238051 |
At a glance
- None 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