# FDA recall Z-0164-2024

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2023-09-26.

## Product

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

## Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

## Distribution

US, Colombia, S. Korea, New Zealand, India, Taiwan

## Key facts

- **Recall number:** Z-0164-2024
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-26
- **Report date:** 2023-11-01

- **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-0164-2024

## Citation

> AI Analytics. FDA recall Z-0164-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0164-2024. Source: US FDA. Licensed CC0.

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