# FDA recall Z-0867-2021

> **Skeletal Kinetics, Llc** · Class II · device recall initiated 2019-06-06.

## Product

OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

## Reason for recall

A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for  the 5cc and 10 cc bone void filler kits. No customer complaints or  reports of injury have been received.

## Distribution

U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.

## Key facts

- **Recall number:** Z-0867-2021
- **Recalling firm:** Skeletal Kinetics, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-06
- **Report date:** 2021-01-27
- **Termination date:** 2024-09-18

- **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-0867-2021

## Citation

> AI Analytics. FDA recall Z-0867-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0867-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*