Device recall
Z-0843-2012: The SternaLock Blu Implant Tray includes plates, screws, screw measuring device…
FDA device recall · Class II · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-0843-2012 |
|---|---|
| Recall event | 60682 |
| Product | The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer containers: Silver Instrument Tray, with a White rack, and there is no Power Driver warning. Labeled in part: "Manufactured… |
| Product code | HRS |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2012 |
| 510(k) numbers | K110574 |
| FEI number | 1032347 |
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