Device recall
Z-2054-2020: Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage…
FDA device recall · Class II · Skeletal Kinetics, Llc
Key facts
| Recall number (Z-number) | Z-2054-2020 |
|---|---|
| Recall event | 85516 |
| Product | Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than 25cm2… |
| Product code | GXP |
| Recalling firm | Skeletal Kinetics, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2025 |
| 510(k) numbers | K162864 |
| FEI number | 3003890476 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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