Device recall
Z-2315-2020: A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item…
FDA device recall · Class II · Biomet
Key facts
| Recall number (Z-number) | Z-2315-2020 |
|---|---|
| Recall event | 85701 |
| Product | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process. |
| Product code | HRS |
| Recalling firm | Biomet |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 8, 2021 |
| 510(k) numbers | K143697 |
| FEI number | 3003506715 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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