FDA Device recall Z-0166-2024
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010 by Medtronic Sofamor Danek Usa, citing 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 requireme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0166-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-26 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | n/a |
Product
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; 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.
Identifiers
| code_info | a) T45001: GTIN 00643169122949, Serial Numbers: A48245-111, A58751-114, A57260-060, A57260-063, A58751-112, A58751-11…a) T45001: GTIN 00643169122949, Serial Numbers: A48245-111, A58751-114, A57260-060, A57260-063, A58751-112, A58751-113, A57260-083, A57260-084, A58428-149, A58428-150, A57260-082, A58428-148, A58751-111, A57260-078, A58428-141, A48245-075, A48245-076, A57260-075, A58751-096, A57260-079, A58428-147, A58428-128, A57260-072, A57260-059, A57260-067, A57260-068, A57260-069, A48245-105, A48245-106, A57256-160, A58751-100, A57256-161, A48245-113, A57256-164, A58799-167, A58799-168, A58799-169, A58799-170, A58799-171, A57256-170, A48245-107, A48245-108, A57256-136, A58751-108, A48245-079, A48245-082, A48245-083, A48245-084, A48245-086, A58751-070, A58751-071, A58751-072, A58751-073, A58751-074, A58751-075, A58751-076, A58751-115, A58799-087, A48245-101, A58799-165, A58799-166, A48245-032, A48245-033, A48245-034, A48245-035, A48245-036, A57260-058, A58799-143, A58799-144, A48245-098, A48245-099, A58428-099, A58428-100, A58428-101, A58428-102, A58428-103, A57260-061, A48245-026, A48245-100, A4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0166-2024%22
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