Device recall
Z-2728-2024: Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in…
FDA device recall · Class II · Stryker Corporation
Key facts
| Recall number (Z-number) | Z-2728-2024 |
|---|---|
| Recall event | 95040 |
| Product | Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic… |
| Product code | HBE |
| Recalling firm | Stryker Corporation |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K210377 |
| FEI number | 3015967359 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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