FDA Device recall Z-0162-2024
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix 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-0162-2024 |
| 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 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.
Identifiers
| code_info | GTIN 00643169123007, Serial Numbers: A57164-040, A58820-011, A57164-041, A57164-042, A59190-046, A59190-041, A59190-0…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 |
|---|
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-0162-2024%22
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