FDA Device recall Z-0163-2024

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210

FDA Device
Class II
ongoing
Published 2023-11-01

On 2023-11-01 the FDA classified a Class II recall of Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210 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-0163-2024
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 DMB Matrix, Model Numbers: a) T42200, b) T42210; 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) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-01… a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A5

code_info

a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-01…

a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A5

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-0163-2024%22

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