# FDA recall Z-1325-2023

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

## Product

Medtronic Grafton Flex:    a)	DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090;  b)	DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090;  c)	DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT;  d)	DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100;  e)	DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS;  f)	DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT;  g)	DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110;  h)	DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS;  i)	DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT;  j)	DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT;  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-1325-2023
- **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-1325-2023

## Citation

> AI Analytics. FDA recall Z-1325-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1325-2023. Source: US FDA. Licensed CC0.

---

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