Device recall
Z-0822-2015: Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0822-2015 |
|---|---|
| Recall event | 69932 |
| Product | Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary… |
| Product code | JDI |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2015 |
| 510(k) numbers | K130610 |
| 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