---
title: "Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix — FDA record Z-0162-2024 | 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-0162-2024-grafton-dbm-flex-model-numbers-t42100-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 (Flex), Model Numbers: T42100, Demineralized Bone Matrix — FDA record Z-0162-2024

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 (Flex), Model Numbers: T42100, 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**: 77 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0162-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0162-2024%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 00643169123007, Serial Numbers: A57164-040, A58820-011, A57164-041, A57164-042, A59190-046, A59190-041, A59190-042, A59190-043, A59190-044, A59190-045, A57164-026, A57164-027, A57164-028, A57164-029, A57164-030, A57164-031, A57164-032, A57164-033, A58820-017, A58820-018, A57164-011, A57164-012, A57164-013, A57164-014, A57164-015, A57164-016, A57164-017, A57164-018, A57164-019, A57164-020, A57164-021, A57164-022, A57164-023, A57164-024, A57164-025, A57164-034, A57164-035, A57164-036, A57164-037, A57164-038, A57164-039, A58820-012, A58820-013, A58820-014, A58820-015, A58820-016, A58820-019, A58820-020, A58820-021, A58820-022, A58820-023, A58820-024, A58820-025, A58820-026, A58820-027, A58820-028, A58820-029, A58820-030, A58820-031, A58820-033, A58820-034, A58820-035, A58820-036, A58820-037, A58820-038, A58820-039, A58820-040, A59190-031, A59190-032, A59190-033, A59190-034, A59190-035, A59190-036, A59190-037, A59190-038, A59190-039, A59190-040 |

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-0162-2024%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/)