Skeletal Kinetics, Llc Recall: CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN,
Skeletal Kinetics, Llc Recall: CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Skeletal Kinetics, Llc; Product: CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated
| Recalling firm | Skeletal Kinetics, Llc |
|---|---|
| Product | CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - 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 to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.- |
| Reason for recall | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, FL, IL, MO, MS, OH, OK, OR, TN, TX, WI and the countries of Australia, Canada, South Africa, Switzerland. |
| Recall initiated | 20200406 |
| Recall number | Z-2602-2020 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
Try RecallGuard →