Device recall
Z-0716-06: ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing…
FDA device recall · Class I · Blackstone Medical Inc.
Key facts
| Recall number (Z-number) | Z-0716-06 |
|---|---|
| Recall event | 34355 |
| Product | ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092 |
| Product code | KWQ |
| Recalling firm | Blackstone Medical Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 9, 2013 |
| 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