Drug recall
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium…
FDA recall event 85516 · Class II · Skeletal Kinetics, Llc
Key facts
| Event ID | 85516 |
|---|---|
| Recall numbers | Z-2054-2020 |
| Recalling firm | Skeletal Kinetics, Llc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc. |
| Initiation date | Apr 3, 2020 |
| Report date | May 27, 2020 |
| Termination date | Jan 30, 2025 |
| City | Addison |
| State | TX |
| Country | United States |
| FEI number | 3003890476 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: