Device recall
Z-2003-2016: Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder…
FDA device recall · Class II · Zimmer Gmbh
Key facts
| Recall number (Z-number) | Z-2003-2016 |
|---|---|
| Recall event | 74206 |
| Product | Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the… |
| Product code | KWS |
| Recalling firm | Zimmer Gmbh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 31, 2016 |
| 510(k) numbers | K142403 |
| FEI number | 3005233524 |
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