# FDA recall Z-1334-2023

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2023-02-08.

## Product

Medtronic XPANSE Bone Insert:   a)	DBM T600106 XPANSE SMALL-C 6, REF T600106;     b)	DBM T600206 XPANSE MEDIUM-C 6, REF T600206;    c)	DBM T600209 XPANSE MEDIUM-C 9, REF T600209;   d)	DBM T600306 XPANSE LARGE-C 6, REF T600306;     e)	DBM T600309 XPANSE LARGE-C 9, REF T600309;    f)	DBM T600612 XPANSE LARGE-L, REF T600612;     Demineralized Bone Matrix (DBM) product

## Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a  breach in the sterile barrier.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

## Key facts

- **Recall number:** Z-1334-2023
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-08
- **Report date:** 2023-04-12

- **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-1334-2023

## Citation

> AI Analytics. FDA recall Z-1334-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1334-2023. Source: US FDA. Licensed CC0.

---

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