Device recall
Z-1214-2019: TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a…
FDA device recall · Class II · TriMed Inc.
Key facts
| Recall number (Z-number) | Z-1214-2019 |
|---|---|
| Recall event | 82209 |
| Product | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in… |
| Product code | HRS |
| Recalling firm | TriMed Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2020 |
| 510(k) numbers | K060041 |
| FEI number | 3001236812 |
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