Device recall
Z-0034-2022: Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
FDA device recall · Class II · Flower Orthopedics Corporation
Key facts
| Recall number (Z-number) | Z-0034-2022 |
|---|---|
| Recall event | 88724 |
| Product | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 |
| Product code | HRS |
| Recalling firm | Flower Orthopedics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2022 |
| 510(k) numbers | K123562 |
| 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