Device recall
Z-0415-2013: Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0415-2013 |
|---|---|
| Recall event | 63613 |
| Product | Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or… |
| Product code | KWA |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2013 |
| 510(k) numbers | K050124 |
| FEI number | 1825034 |
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