Device recall
Z-1020-2012: DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE…
FDA device recall · Class II · Wright Medical Technology Inc
Key facts
| Recall number (Z-number) | Z-1020-2012 |
|---|---|
| Recall event | 60947 |
| Product | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. |
| Product code | KWA |
| Recalling firm | Wright Medical Technology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2013 |
| 510(k) numbers | K082924 |
| FEI number | 1043534 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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