# FDA recall Z-1328-2023

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

## Product

Medtronic Grafton Matrix Strips:    a)	DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275;   b)	DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280;   c)	DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275;   d)	DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS;   e)	DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT;   f)	DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN;   g)	DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280;   h)	DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS;   i)	DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT;   j)	DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN;   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-1328-2023
- **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-1328-2023

## Citation

> AI Analytics. FDA recall Z-1328-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1328-2023. Source: US FDA. Licensed CC0.

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