Device recall
Z-0448-2022: Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be…
FDA device recall · Class II · Flower Orthopedics Corporation
Key facts
| Recall number (Z-number) | Z-0448-2022 |
|---|---|
| Recall event | 89092 |
| Product | Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1 |
| Product code | HSB |
| Recalling firm | Flower Orthopedics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 12, 2023 |
| 510(k) numbers | K202858 |
| FEI number | 3009996260 |
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