# FDA recall Z-1329-2023

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

## Product

Medtronic Grafton Plus Paste   a)	DBM S45001 GRAFTON 1CC PASTE, REF S45001;    b)	DBM S45005 GRAFTON 5CC PASTE, REF S45005;     c)	DBM S45010 GRAFTON 10CC PASTE, REF S45010;     d)	DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001;   e)	DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS;   f)	DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT;   g)	DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005;   h)	DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT;   i)	DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010;   j)	DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS;   k)	DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT;   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-1329-2023
- **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-1329-2023

## Citation

> AI Analytics. FDA recall Z-1329-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1329-2023. Source: US FDA. Licensed CC0.

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