Medtronic Sofamor Danek USA Inc: Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Hazard

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.

Details from the source

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. Distribution: US, Colombia, S. Korea, New Zealand, India, Taiwan Quantity: 583 units Lot/code info: 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, A48245-027, A48245-028, A48245-029, A48245-030, A48245-031, A58751-077, A58751-078, A58751-079, A58751-080, A57260-064, A57260-065, A57260-066, A58428-086, A58428-087, A58428-088, A57256-145, A57256-146, A57256-147, A57256-148, A57256-149, A57256-150, A48245-018, A58799-099, A58799-100, A58799-113, A58799-114, A48245-053, A58799-123, A48245-080, A48245-081, A58428-107, A58428-108, A58428-109, A58428-110, A57256-137, A57256-138, A57256-139, A57256-140, A58799-107, A58799-108, A58799-109, A58751-083,

UPC codes

00643169122949, 00643169123021, 00643169123038

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.