medical Class II Updated 2023-11-01

Medtronic Sofamor Danek USA Inc recalls Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bon

Recalled Product

Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix

Hazard / Issue

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.

Issued by

FDA

Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan
Lot/Code Info: 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
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