# FDA recall Z-1331-2023

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

## Product

Medtronic Grafton DBF Inject:  a)	GRAFTON T50303 DBF INJECT 3CC, REF T50303;     b)	GRAFTON T50306 DBF INJECT 6CC, REF T50306;     c)	GRAFTON T50309 DBF INJECT 9CC, REF T50309;    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-1331-2023
- **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-1331-2023

## Citation

> AI Analytics. FDA recall Z-1331-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1331-2023. Source: US FDA. Licensed CC0.

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