# FDA recall Z-2602-2020

> **Skeletal Kinetics, Llc** · Class II · device recall initiated 2020-04-06.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2602-2020
- **Recalling firm:** Skeletal Kinetics, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-06
- **Report date:** 2020-07-22
- **Termination date:** 2021-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Addison, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2020

## Citation

> AI Analytics. FDA recall Z-2602-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2602-2020. Source: US FDA. Licensed CC0.

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