# FDA recall Z-0440-2019

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2018-09-27.

## Product

INFUSE Bone Graft X SMALL KIT REF 7510100

## Reason for recall

The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.

## Distribution

US

## Key facts

- **Recall number:** Z-0440-2019
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-27
- **Report date:** 2018-11-21
- **Termination date:** 2020-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0440-2019

## Citation

> AI Analytics. FDA recall Z-0440-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0440-2019. Source: US FDA. Licensed CC0.

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