Device recall
Z-2601-2020: CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368…
FDA device recall · Class II · Skeletal Kinetics, Llc
Key facts
| Recall number (Z-number) | Z-2601-2020 |
|---|---|
| Recall event | 85517 |
| Product | CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury… |
| Product code | GXP |
| Recalling firm | Skeletal Kinetics, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2021 |
| 510(k) numbers | K042072 |
| FEI number | 3003890476 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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