Device recall
Z-2016-2020: K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless…
FDA device recall · Class II · K2M, Inc
Key facts
| Recall number (Z-number) | Z-2016-2020 |
|---|---|
| Recall event | 85491 |
| Product | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on… |
| Product code | HWJ |
| Recalling firm | K2M, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2021 |
| FEI number | 3008599177 |
At a glance
- None Linked 510(k)s
- 10–99 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