Device recall
Z-0032-2009: Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0032-2009 |
|---|---|
| Recall event | 49465 |
| Product | Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant. |
| Product code | JDC |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 22, 2009 |
| 510(k) numbers | K013042 |
| FEI number | 1825034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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