Recall archive / FDA device enforcement

Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005... — FDA record Z-1329-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 8, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product
Reason: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Classification: Class II
Recalling firm: Medtronic Sofamor Danek USA Inc
Quantity: 37721 units
Agency-reported status: Ongoing
Source record identifier: Z-1329-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, A24679-163, A24679-164, A24679-165, A24679-166, A24679-167, A24679-168, A24679-169, A24679-170, A24679-171, A24679-172, A24679-173, A24679-176, A24679-177, A24679-178, A24679-179, A24679-180, A24679-181, A24679-182, A24679-183, A24679-184, A24679-185, A24679-186, A24679-187, A24679-188, A24679-189, A24679-190, A24679-191, A24679-192, A24679-193, A24679-194, A24679-195, A24679-196, A24679-197, A24679-198, A24679-199, A24679-200, A24679-201, A24679-202, A24679-203, A24679-204, A24679-205, A24679-206, A24679-207, A24679-208, A24679-209, A24679-210, A24679-211, A24679-212, A24679-213, A24679-214, A24679-215, A24679-216, A24679-217, A24679-218, A24679-219, A24679-220, A24679-221, A24679-222, A24679-223, A24679-224, A24679-225, A24679-226, A24679-227, A38900-127, A38900-128, A38900-129, A38900-130, A38900-131, A38900-132, A38900-133, A38900-134, A38900-135, A38900-136, A38900-137, A38900-138, A38900-139, A38900-140, A38900-141, A38900-142, A38900-143, A38900-145, A38900-146, A38900-147, A38900-148, A38900-149, A38900-150, A38900-151, A38900-152, A38900-153, A38900-154, A38900-155, A38900-156, A38900-157, A38900-158, A38900-159, A38900-160, A38900-161, A38900-162, A38900-163, A38900-164, A38900-165, A38900-166, A38900-167, A38900-168, A38900-169, A38900-170, A38900-171, A38900-172, A38900-173, A38900-174, A38900-175, A38900-176, A38900-177, A38900-178, A38900-179, A38900-180, A38900-181, A38900-182, A38900-183, A38900-184, A38900-185, A38900-186, A38900-187, A38900-188, A38900-189, A38900-190, A38900-191, A38900-192, A38900-193, A38900-194, A38900-195, A38900-196, A38900-197, A38900-198, A38900-199, A38900-200, A38900-201, A38900-202, A38900-203, A38900-204, A38900-205, A38900-206, A38916-075, A38916-076, A38916-077, A38916-078, A38916-079, A38916-080, A38916-081, A38916-082, A38916-083, A38916-084, A38916-085, A38916-086, A38916-087, A38916-088, A38916-089, A38916-090, A38916-091, A38916-092, A38916-093, A38916-094, A38916-095, A38916-096, A39200-016, A39200-017, A39200-018, A39200-019, A39200-020, A39200-021, A39200-022, A39200-023, A39200-024, A39200-025, A39200-026, A39200-027, A39200-028, A39200-029, A39200-030, A39200-031, A39200-032, A39200-033, A39200-034, A39200-035, A39200-037, A39200-038, A39200-039, A39200-040, A39200-041, A39200-042, A39200-043, A39200-044, A39200-045, A39200-046, A39200-047, A39200-048, A39200-049, A39200-050, A39200-051, A39200-052, A39200-053, A39200-054, A39200-055, A39200-056, A39200-057, A39200-058, A39200-059, A39200-060, A39200-061, A39200-062, A39200-063, A39200-064, A39200-065, A39200-066, A39200-067, A39200-068, A39200-069, A39200-070, A39200-071, A39200-072, A39200-073, A39200-074, A39200-075, A39200-076, A39200-077, A39200-078, A39200-079, A39200-080, A39200-081, A39200-082, A39200-083, A39200-084, A39200-085, A39200-086, A39200-087, A39200-088, A39200-089, A39200-090, A39200-091, A39200-092, A39200-093, A39200-094, A39200-095, A39200-096, A39805-083, A39805-084, A39805-085, A39805-086, A39805-087, A39805-088, A39805-089, A39805-090, A39805-091, A39805-092, A39805-093, A39805-094, A39805-095, A39805-096, A39805-097, A39805-098, A39805-099, A39805-100, A39805-101, A39805-102, A39805-103, A39805-104, A39805-105, A39805-106, A39805-107, A39805-108, A39805-109, A39805-110, A39805-111, A39805-112, A39805-113, A39805-114, A39805-115, A39805-116, A39805-117, A39805-118, A39805-119, A39805-120, A39805-121, A39805-122, A39805-123, A39805-124, A39805-125, A39805-126, A39805-127, A39805-128, A39805-129, A39805-130, A39805-131, A39805-132, A39805-133, A39805-134, A39805-135, A39805-136, A39805-137, A39805-138, A39805-139, A39805-140, A39805-141, A39805-142, A39805-143, A39805-144, A39805-145, A39805-146, A39805-147, A39805-148, A39805-149, A39805-150, A39805-151, A39805-152, A39805-153, A39805-154, A39805-155, A39805-156, A39805-157, A39805-158, A39805-159, A39805-160, A39805-161, A39805-162, A39805-163, A39805-164, A39805-165, A39805-166, A39805-167, A39861-011, A39861-012, A39861-013, A39861-014, A39861-015, A39861-016, A39861-017, A39861-018, A39861-019, A39861-020, A39861-021, A39861-022, A39861-023, A39861-024, A39861-026, A39861-027, A39861-028, A39861-029, A39861-030, A39861-031, A39861-032, A39861-033, A39861-034, A39861-035, A39861-036, A39861-037, A39861-038, A39861-039, A39861-040, A39861-041, A39861-042, A39861-043, A39861-044, A39861-045, A39861-046, A39861-047, A39861-048, A39861-049, A39861-050, A39861-051, A39861-052, A39861-053, A39861-054, A39861-055, A39861-056, A39861-057, A39861-058, A39861-059, A39861-060, A39861-061, A40002-026, A40002-027, A40002-028, A40002-029, A40002-030, A40002-031, A40002-032, A40002-033, A40002-034, A40002-035, A40002-036, A40002-037, A40002-038, A40002-039, A40002-040, A40002-041, A40002-042, A40002-043, A40002-044, A40002-045, A40002-046, A40002-047, A40002-048, A40002-049, A40002-050, A40002-051, A40002-052, A40002-053, A40002-054, A40002-055, A40002-056, A40002-057, A40002-058, A40002-059, A40002-060, A40002-061, A40002-062, A40002-063, A40002-064, A40002-065, A40002-066, A40002-067, A40002-068, A40002-069, A40002-070, A40002-071, A40002-072, A40002-073, A40002-074, A40002-075, A40002-076, A40002-077, A40002-078, A40002-079, A40002-080, A40002-081, A40002-082, A40173-104, A40173-105, A40173-106, A40173-107, A40173-108, A40173-109, A40173-110, A40173-111, A40173-112, A40173-113, A40173-114, A40173-115, A40173-116, A40173-117, A40173-118, A40173-119, A40173-120, A40173-121, A40173-122, A40173-123, A40173-124, A40173-125, A40173-126, A40173-127, A40173-128, A40173-129, A40173-130, A40173-131, A40173-132, A40173-133, A40173-134, A40173-135, A40173-136, A40173-137, A40173-138, A40173-139, A40173-140, A40173-141, A40173-142, A40173-143, A40173-144, A40173-145, A40173-146, A40173-147, A40173-148, A40173-149, A40173-150, A40173-151, A40173-152, A40173-153, A40173-154, A40173-155, A40173-156, A40173-157, A40173-158, A40173-159, A40173-160, A40173-161, A40213-051, A40213-052, A40213-053, A40213-054, A40213-055, A40213-056, A40213-057, A40213-058, A40213-059, A40213-060, A40213-061, A40213-062, A40213-063, A40213-064, A40213-065, A40213-066, A40213-067, A40213-068, A40213-069, A40213-070, A40213-071, A40213-072, A40213-073, A40213-074, A40213-075, A40213-076, A40213-077, A40213-078, A40213-079, A40213-080, A40213-081, A40213-082, A40213-083, A40213-084, A40213-085, A40213-086, A40213-087, A40213-088, A40213-089, A40213-090, A40213-091, A40213-092, A40213-093, A40213-099, A40213-100, A40213-101, A40213-102, A40213-103, A40213-104, A40213-105, A40213-106, A40213-107, A40213-108, A40213-109, A40213-110, A40379-051, A40379-052, A40379-053, A40379-054, A40379-055, A40379-056, A40379-057, A40379-058, A40379-059, A40379-060, A40379-061, A40379-062, A40379-063, A40379-064, A40379-065, A40379-066, A40379-067, A40379-068, A40379-069, A40379-070, A40379-071, A40379-072, A40379-073, A40379-074, A40379-075, A40379-076, A40379-077, A40379-078, A40379-079, A40379-080, A40379-081, A40379-082, A40379-083, A40379-084, A40379-085, A40379-086, A40379-087, A40379-088, A40379-089, A40379-090, A40379-091, A40379-092, A40379-093, A40379-094, A40711-096, A40711-097, A40711-098, A40711-099, A40711-100, A40711-101, A40711-102, A40711-103, A40711-104, A40711-105, A40711-106, A40711-107, A40711-108, A40711-109, A40711-110, A40711-111, A40711-112, A40711-113, A40711-114, A40711-115, A40711-116, A40711-117, A40711-118, A40711-119, A40711-120, A40711-121, A40711-122, A40711-123, A40711-124, A40711-125, A40711-126, A40711-127, A40711-128, A40711-129, A40711-130, A40711-131, A40711-132, A40711-133, A40711-134, A40711-135, A40711-136, A40711-137, A40711-138, A40711-139, A40711-140, A40711-141, A40711-142, A40711-143, A40711-144, A40711-145, A40711-146, A40711-147, A40711-148, A40711-149, A40711-150, A40711-151, A40711-152, A40711-153, A40711-154, A40711-155, A40711-156, A40711-157, A40711-158, A40711-159, A40711-160, A40711-161, A40711-162, A40711-163, A40711-164, A40711-165, A40711-166, A40711-167, A40711-168, A40711-169, A40711-170, A40711-171, A40711-172, A40711-173, A40711-174, A40711-175, A40711-176, A40711-177, A40711-178, A40711-179, A40711-180, A40711-181, A40711-182, A40711-183, A40711-184, A40711-185, A40711-186, A40711-187, A40711-188, A40752-053, A40752-054, A40752-055, A40752-056, A40752-057, A40752-058, A40752-059, A40752-060, A40752-061, A40752-062, A40752-063, A40752-064, A40752-090, A40752-091, A40752-092, A40752-093, A40752-094, A40752-095, A40752-096, A40752-097, A40752-098, A40752-099, A40752-100, A40752-101, A40752-102, A40752-103, A40752-104, A40752-105, A40752-106, A40752-107, A40752-108, A40752-109, A40752-110, A40752-111, A40752-112, A40752-113, A40752-114, A40752-115, A40752-116, A40752-117, A40752-118, A40752-119, A40752-120, A40752-121, A40752-122, A40752-123, A40752-124, A40752-125, A40752-126, A40851-011, A40851-012, A40851-013, A40851-014, A40851-015, A40851-016, A40851-017, A40851-018, A40851-019, A40851-020, A40851-021, A40851-022, A40851-023, A40851-024, A40851-025, A40851-026, A40851-027, A40851-028, A40851-029, A40851-030, A40851-031, A40851-032, A40851-033, A40851-034, A40851-035, A40851-036, A40851-037, A40851-038, A40851-039, A40851-040, A40851-041, A40851-042, A40851-043, A40851-044, A40851-045, A40851-046, A40851-047, A40851-048, A40851-049, A40851-050, A40851-051, A40851-052, A40851-053, A40851-054, A40851-055, A40851-056, A40851-057, A40851-058, A40851-059, A40851-060, A40851-061, A40851-062, A40851-063, A40851-064, A40851-065, A40851-066, A40851-067, A40851-068, A40851-069, A40956-026, A40956-027, A40956-028, A40956-029, A40956-030, A40956-031, A40956-032, A40956-033, A40956-034, A40956-035, A40956-036, A40956-037, A40956-038, A40956-039, A40956-040, A40956-041, A40956-042, A40956-043, A40956-044, A40956-045, A40956-046, A40956-047, A40956-048, A40956-049, A40956-050, A40956-051, A40956-052, A40956-053, A40956-054, A40956-055, A40956-056, A40956-057, A41003-026, A41003-027, A41003-028, A41003-029, A41003-030, A41003-031, A41003-032, A41003-033, A41003-034, A41003-035, A41003-036, A41003-037, A41003-038, A41003-039, A41003-040, A41003-041, A41003-042, A41003-043, A41003-044, A41003-045, A41003-046, A41003-047, A41003-048, A41003-049, A41003-050, A41003-051, A41003-052, A41003-053, A41003-054, A41003-055, A41003-056, A41003-057, A41003-058, A41003-059, A41003-060, A41003-061, A41003-062, A41003-064, A41003-065, A41003-066, A41003-067, A41003-068, A41003-069, A41003-070, A41003-071, A41003-072, A41003-073, A41003-074, A41003-075, A41003-076, A41003-077, A41003-078, A41003-079, A41167-071, A41167-072, A41167-074, A41167-075, A41167-076, A41167-077, A41167-078, A41167-079, A41167-080, A41167-081, A41167-082, A41167-083, A41167-084, A41167-085, A41167-086, A41167-087, A41167-088, A41167-089, A41167-090, A41167-091, A41167-092, A41167-093, A41167-094, A41167-095, A41167-096, A41167-097, A41167-098, A41167-099, A41167-100, A41167-101, A41167-102, A41167-103, A41167-104, A41167-105, A41167-106, A41167-107, A41167-108, A41167-109, A41167-...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, A24679-163, 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A41167-107, A41167-108, A41167-109, A41167-...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 12, 2023
Recall initiation date: Feb 8, 2023
Center classification date: Apr 4, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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