Device recall
Z-1655-2009: Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant…
FDA device recall · Class II · Blackstone Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1655-2009 |
|---|---|
| Recall event | 52051 |
| Product | Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants. |
| Product code | MNI |
| Recalling firm | Blackstone Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2015 |
| 510(k) numbers | K042514 |
| FEI number | 3001238051 |
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