---
title: "Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix — FDA record Z-0161-2024 | Is It on Recall"
description: "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 acc"
url: https://isitonrecall.com/recall/fda-device-z-0161-2024-grafton-dbm-crunch-model-numbers-t44115-demineralized-bone-matrix/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix — FDA record Z-0161-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 26, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Medtronic Sofamor Danek USA Inc
- **Quantity**: 84 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0161-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0161-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | GTIN 00643169123113, Serial Numbers: A59083-054, A59083-055, A59083-056, A59083-057, A59083-058, A59083-059, A59083-060, A59083-061, A59083-062, A59083-063, A59083-064, A56737-049, A56737-050, A56737-051, A56737-052, A56737-053, A56737-054, A56737-055, A56737-056, A56737-057, A56737-058, A56737-059, A56737-060, A56737-061, A56737-062, A56737-063, A56858-021, A56858-022, A56858-023, A56858-024, A56858-025, A56858-026, A56858-027, A56858-028, A56858-029, A56858-030, A56858-031, A56858-032, A56858-033, A56858-034, A56858-035, A56858-036, A57174-060, A57174-061, A57174-062, A57174-063, A57174-064, A57174-065, A57174-066, A57174-067, A57174-068, A57174-069, A57174-070, A57174-071, A57617-066, A57617-067, A57617-068, A57617-069, A57617-070, A57617-071, A57617-072, A57617-073, A57617-074, A57617-075, A57617-076, A57617-077, A57617-078, A58281-035, A58281-036, A58281-037, A58281-038, A58281-039, A58281-040, A58281-041, A58281-042, A58281-043, A58281-044, A58281-045, A58281-046, A58281-047, A59083-050, A59083-051, A59083-052, A59083-053 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Nov 1, 2023
- **Recall initiation date**: Sep 26, 2023
- **Center classification date**: Oct 24, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0161-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Sofamor Danek USA Inc records](https://isitonrecall.com/brand/medtronic-sofamor-danek-usa-inc/)