Device recall
Z-1521-2021: Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel…
FDA device recall · Class II · Oto Med Inc
Key facts
| Recall number (Z-number) | Z-1521-2021 |
|---|---|
| Recall event | 87577 |
| Product | Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use. |
| Product code | MXP |
| Recalling firm | Oto Med Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2021687 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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