Device recall
Z-0309-2011: 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and…
FDA device recall · Class II · Synthes USA (HQ), Inc.
Key facts
| Recall number (Z-number) | Z-0309-2011 |
|---|---|
| Recall event | 56837 |
| Product | 3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone |
| Product code | HRS |
| Recalling firm | Synthes USA (HQ), Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2015 |
| 510(k) numbers | K082625 |
| FEI number | 3005180112 |
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