Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
Summary
The FDA issued a Class II for Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Deminera by Medtronic Sofamor Danek USA Inc. 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 per.
Details
Source
Device Recall
External ID
Z-0166-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix
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, A58751-084, A58751-085, A48245-022, A48245-023, A58428-111, A58428-112, A58428-113, A58428-114, A58751-086, A58751-087, A58751-088, A58751-089, A57256-172, A58428-115, A58428-116, A58799-119, A58799-120, A58799-124, A58799-125, A48245-037, A48245-038, A57256-133, A57256-134, A57256-135, A57256-142, A57256-143, A57256-144, A58751-081, A58799-172, A58799-173, A58799-174, A58799-175, A58799-176, A58799-177, A58799-092, A58799-093, A58428-117, A58428-118, A48245-019, A48245-020, A48245-021, A58799-128, A58799-129, A58799-130, A58799-131, A58799-132, A48245-087, A48245-088, A57260-080, A57260-081, A58428-119, A58799-134, A58751-090, A48245-042, A48245-043, A48245-095, A48245-096, A48245-097, A58428-120, A58428-121, A58428-122, A58751-091, A58799-135, A58799-136, A58799-137, A58799-138, A58799-139, A48245-074, A48245-094, A48245-044, A48245-045, A48245-046, A58751-093, A58751-094, A58751-095, A58428-123, A58428-124, A58428-125, A58428-144, A58428-145, A58428-146, A48245-085, A48245-116, A48245-039, A48245-040, A48245-041, A58428-104, A58428-105, A58428-106, A58799-102, A58799-103, A58799-104, A58799-105, A48245-089, A48245-090, A48245-091, A48245-092, A48245-093, A48245-077, A57260-076, A57260-077, A58428-126, A58428-127, A58799-121, A58799-122, A58799-126, A58799-127, A58799-094, A58799-095, A48245-112, A58751-097, A58751-092, A58799-097, A58799-098, A58428-130, A58428-131, A58428-132, A58428-133, A58428-134, A57260-073, A57260-074, A58799-088, A58799-089, A58799-090, A58799-091, A58799-140, A58799-141, A58799-142, A58799-145, A58799-146, A58799-147, A58799-148, A58799-149, A58799-150, A58799-151, A58799-152, A58799-153, A58799-154, A58799-155, A58799-156, A58799-157, A58799-158, A58799-159, A58799-160, A58799-161, A58799-162, A57256-171, A48245-054, A48245-055, A58751-098, A58751-099, A48245-117, A48245-118, A48245-119, A48245-120, A57260-070, A57260-071, A48245-102, A58799-101, A58799-163, A58799-164, A58799-106, A58799-110, A58799-111, A58799-112, A58799-115, A58799-116, A58799-117, A58799-118, A57256-141, A58428-139, A48245-109, A48245-110, A57256-157, A57256-158, A57256-159, A48245-114, A48245-115, A48245-056, A48245-057, A48245-068, A48245-069, A48245-070, A48245-071, A48245-072, A48245-073, A48245-078, A58751-101, A58751-102, A58751-103, A58751-104, A58751-105, A48245-048, A48245-049, A48245-050, A48245-051, A48245-052, A58428-090, A58428-091, A58428-092, A58428-093, A58428-135, A58428-136, A58751-106, A58799-133, A58751-109, A58751-110, A58751-082, A58799-096, A57256-162, A57256-163, A58428-142, A48245-058, A58428-129, A57256-165, A48245-024, A48245-025, A58428-089, A58428-143, A58751-067, A58751-068, A58751-069, A57256-166, A58428-140, A48245-047, A58428-137, A58428-138, A57256-151, A57256-152, A57256-153, A57256-154, A57256-155, A57256-156, A58428-094, A58428-095, A58428-096, A58428-097, A58428-098, A48245-059, A48245-060, A48245-061, A48245-062, A48245-063, A48245-064, A48245-065, A48245-066, A48245-067, A57260-062, A58751-107, A57256-167, A57256-168, A57256-169, A48245-103, A48245-104; b) T45005: GTIN 00643169123021, Serial Numbers: A58746-016, A57923-013, A59083-037, A57923-022, A57878-072, A58720-014, A58720-015, A57261-045, A57261-046, A57261-047, A59083-048, A58973-023, A58973-024, A58973-025, A58973-026, A58973-027, A59132-021, A59132-022, A59132-023, A59132-024, A59132-025, A59132-026, A59132-027, A59132-028, A59132-029, A59132-030, A57878-063, A57878-064, A57878-065, A57878-066, A57878-067, A58973-029, A58973-033, A58746-013, A58746-015, A58746-014, A57923-021, A59083-049, A57923-011, A57923-012, A58746-018, A58746-019, A58746-020, A58746-021, A58746-024, A57878-068, A57878-069, A58973-028, A58746-023, A58746-025, A58746-029, A58746-030, A58746-031, A58746-032, A57878-070, A57878-071, A58746-026, A58746-027, A57923-014, A57923-015, A57261-039, A57261-040, A57261-041, A57261-042, A57261-043, A57261-044, A58746-028, A59083-036, A59083-038, A58746-011, A58746-012, A58746-017, A58973-011, A58973-012, A58973-013, A58973-014, A58973-015, A58973-016, A58973-017, A58973-018, A58973-019, A58973-020, A58973-021, A58973-022, A58720-023, A57878-073, A57878-074, A57261-038, A59083-039, A59083-040, A59083-041, A57261-056, A57878-075, A57878-076, A57261-048, A57261-049, A57261-050, A58720-011, A58720-012, A57261-051, A57261-052, A59083-042, A57261-055, A57261-057, A59083-043, A57261-053, A57261-054, A58720-013, A58720-016, A58720-017, A59083-044, A57923-016, A57923-017, A57923-018, A57923-023, A58973-030, A58973-031, A59083-045, A59129-032, A59129-041, A57923-019, A58720-018, A58720-019, A58720-020, A58720-021, A58720-022, A58973-032, A57923-020, A59083-046, A59083-047, A58746-022, A59132-011, A59132-012, A59132-013, A59132-014, A59132-015, A59132-016, A59132-017, A59132-018, A59132-019, A59132-020; c) T45010: GTIN 00643169123038, Serial Numbers: A59231-018, A59231-019, A56269-064, A59231-014, A56269-066, A59010-019, A59010-021, A59010-022, A59010-023, A56269-071, A56269-072, A59356-017, A59356-018, A59131-019, A59131-020, A59191-026, A59231-020, A59231-015, A59231-016, A59231-017, A59010-024, A59010-025, A56269-065, A59131-011, A59131-012, A59131-013, A59356-011, A59356-012, A59356-013, A59231-013, A56269-061, A56269-062, A56269-063, A59010-026, A59010-027, A59131-014, A59131-015, A59131-016, A59131-017, A59131-018, A59191-027, A59191-028, A59191-029, A59191-030, A59191-031, A59191-032, A59191-033, A59010-020, A56269-067, A56269-068, A59191-034, A59191-035, A59191-036, A59356-020, A59191-037, A59231-011, A59356-019, A56269-069, A56269-070, A59010-016, A59010-017, A59231-012, A59356-014, A59356-015, A56269-060, A59010-018, A59356-016
Quantity Affected: 583 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-26
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Sofamor Danek USA Inc has 60 FDA actions in our database, including 37 recalls and 23 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Sofamor Danek USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Sofamor Danek USA Inc have FDA actions?
Medtronic Sofamor Danek USA Inc has 60 FDA actions in our database, including 37 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0166-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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