Device recall
Z-1615-2014: ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1615-2014 |
|---|---|
| Recall event | 68144 |
| Product | ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant. |
| Product code | KWI |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2015 |
| 510(k) numbers | K040611, K051385 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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