Device recall
Z-1238-2011: Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines…
FDA device recall · Class II · Stryker Instruments Division of Stryker Corporation
Key facts
| Recall number (Z-number) | Z-1238-2011 |
|---|---|
| Recall event | 57505 |
| Product | Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic… |
| Product code | HBE |
| Recalling firm | Stryker Instruments Division of Stryker Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2011 |
| 510(k) numbers | K032303 |
| FEI number | 1811755 |
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