Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
FDA Recall #Z-0162-2024 — Class II — September 26, 2023
Product Description
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Reason for Recall
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.
Recalling Firm
Medtronic Sofamor Danek USA Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
77 units
Distribution
US, Colombia, S. Korea, New Zealand, India, Taiwan
Code Information
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
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated