Device recall
Z-1521-2012: Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For…
FDA device recall · Class III · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1521-2012 |
|---|---|
| Recall event | 61685 |
| Product | Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and… |
| Product code | JXE |
| Recalling firm | Biomet, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 18, 2013 |
| 510(k) numbers | K031280 |
| FEI number | 1825034 |
At a glance
- 1–9 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