Device recall
Z-1014-2018: BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in…
FDA device recall · Class II · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1014-2018 |
|---|---|
| Recall event | 78706 |
| Product | BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement |
| Product code | KWY |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 2, 2020 |
| 510(k) numbers | K833991 |
| FEI number | 1000220733 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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