Device recall
Z-0074-2024: Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream…
FDA device recall · Class II · Flower Orthopedics Corporation
Key facts
| Recall number (Z-number) | Z-0074-2024 |
|---|---|
| Recall event | 93024 |
| Product | Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S |
| Product code | HSB |
| Recalling firm | Flower Orthopedics Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 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