Device recall
Z-0269-2018: ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is…
FDA device recall · Class II · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0269-2018 |
|---|---|
| Recall event | 78705 |
| Product | ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom… |
| Product code | KWI |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 6, 2018 |
| 510(k) numbers | 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