Device recall
Z-0886-2017: Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate…
FDA device recall · Class II · Amendia, Inc
Key facts
| Recall number (Z-number) | Z-0886-2017 |
|---|---|
| Recall event | 75869 |
| Product | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region |
| Product code | KWQ |
| Recalling firm | Amendia, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2017 |
| 510(k) numbers | K081770 |
| FEI number | 3007970248 |
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