Device recall
Z-1071-2012: Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550…
FDA device recall · Class II · Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1071-2012 |
|---|---|
| Recall event | 60971 |
| Product | Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Sterile, Biomet Orthopedics Warsaw IN 46581. Intended for primary and revision joint arthroplasty for use in cemented applications. |
| Product code | JDC |
| Recalling firm | Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2012 |
| 510(k) numbers | K051975 |
| 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