Recall archive / FDA device enforcement

Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM ... — FDA record Z-1333-2023

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 Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; 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: 10090 units
Agency-reported status: Ongoing
Source record identifier: Z-1333-2023

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 S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC, REF S41150, GTIN 00613994961143, Serial Numbers: A43939, A47225 c) DBM T41110 0.5CC GRAFTON GEL, REF T41110, GTIN 00643169122956, Serial Numbers: A38528-100, A38528-101, A38528-102, A38528-103, A38528-104, A38528-105, A38528-106, A38910-058, A38910-059, A38910-060, A38910-061, A38910-062, A41224-053, A41224-054, A41224-055, A41224-056, A41224-057, A41224-058, A41224-059, A41224-060, A41224-061, A41224-062, A41224-063, A41224-064, A41224-065, A41224-066, A41224-067, A41224-068, A41224-069, A41224-070, A41224-071, A41224-072, A41935-025, A41935-026, A41935-027, A41935-028, A41935-029, A41935-030, A41935-031, A41935-032, A41935-033, A41935-034, A41935-035, A41935-036, A41935-037, A41935-038, A41935-039, A41935-040, A41935-041, A41935-042, A41935-043, A41935-044, A41935-045, A41935-046, A41935-047, A41935-048, A41935-049, A41935-050, A41935-051, A41935-052, A41935-053, A42221-076, A42221-077, A42221-078, A42221-079, A42221-080, A42221-081, A42221-082, A42221-083, A42221-084, A42221-085, A42619-011, A42619-012, A42619-013, A42619-014, A42619-015, A42619-016, A42619-017, A42619-018, A42619-019, A42619-020, A42619-021, A42619-022, A42619-023, A42619-024, A42619-025, A42619-026, A42619-027, A42619-028, A42619-029, A42619-030, A42619-031, A42619-032, A42619-033, A42619-034, A42619-035, A42619-036, A43231-127, A43231-128, A43286-011, A43286-012, A43286-013, A43286-014, A43286-015, A43286-016, A43286-017, A43286-018, A43286-019, A43286-020, A43286-021, A43286-022, A43286-023, A43286-024, A43286-025, A43286-026, A43286-027, A43286-028, A43286-029, A43286-030, A43286-031, A43286-032, A43286-033, A43286-034, A43286-035, A43286-036, A43286-037, A43286-038, A43286-039, A43286-040, A43286-041, A43286-042, A43286-043, A43286-044, A43286-045, A43286-046, A43286-047, A43286-048, A43286-049, A43286-050, A43286-051, A43286-052, A43286-053, A43286-054, A43286-055, A43286-056, A43286-057, A43286-058, A43286-059, A43286-060, A43286-061, A46158-011, A46158-012, A46158-013, A46158-014, A46158-015, A46158-016, A46158-017, A46158-018, A46158-019, A46158-020, A46158-021, A46158-022, A46158-023, A46158-024, A46158-025, A46158-026, A46158-027, A46158-028, A46158-029, A46158-030, A46158-031, A46158-032, A46158-033, A46158-034, A46158-035, A46158-036, A46158-037, A46158-038, A46158-039, A46158-040, A46158-041, A46158-042, A46158-043, A46158-044, A46158-045, A46158-046, A46158-047, A46158-048, A46158-049, A46158-050, A46158-051, A46158-052, A46158-053, A46158-054, A46158-055, A46158-056, A47115-011, A47115-012, A47115-013, A47115-014, A47115-015, A47115-016, A47115-017, A47115-018, A47115-019, A47115-020, A47115-021, A47115-022, A47115-023, A47115-024, A47115-025, A47115-026, A47115-027, A47115-028, A47115-029, A47115-030, A47115-031, A47115-032, A47115-033, A47115-034, A47115-035, A47115-036, A47115-037, A47115-038, A47115-039, A47115-040, A47293-011, A47293-012, A47293-013, A47293-014, A47293-015, A47293-016, A47293-017, A47293-018, A47293-019, A47293-020, A47293-021, A47293-022, A47293-023, A47293-024, A47293-025, A47293-026, A47293-027, A47293-028, A47293-029, A47293-030, A47293-031, A47293-032, A47293-033, A47293-034, A47293-035, A47293-036, A47431-041, A47431-042, A47431-043, A47431-044, A47431-045, A47431-046, A47431-047, A47431-048, A47431-049, A47431-050, A47431-051, A47431-052, A47431-053, A47431-054, A47431-055, A47431-056, A47431-057, A47431-058, A47431-059, A47431-060, A47431-061, A47431-062, A47431-063, A47431-064, A47431-065, A47431-066, A47431-067, A47431-068, A47431-069, A47431-070, A47431-071, A47431-072, A47431-073, A47431-074, A47431-075, A47431-076, A47431-077, A47431-078, A47431-079, A47431-080, A47431-081, A47431-082, A47573-030, A47573-031, A47573-032, A47573-033, A47573-034, A47573-035, A47573-036, A47573-037, A47573-038, A47573-039, A47573-040, A47573-041, A47573-042, A47573-043, A47573-044, A47573-045, A47573-046, A47573-047, A47573-048, A47573-049, A47573-050, A47573-051, A47573-052, A47573-053, A47573-054, A47573-055, A47573-056, A47573-057, A47573-058, A47573-059, A47573-060, A47573-061, A47573-062, A47573-063, A47573-064, A47573-065, A47573-066, A47573-067, A47573-068, A47573-069, A47573-070, A47573-071, A47573-072, A47573-073, A47573-074, A47573-075, A47573-076, A47573-077, A47573-078, A47573-079, A47573-080, A47573-081, A47573-082, A47573-083, A47573-084, A47573-085, A47573-086, A47573-087, A47573-088, A47573-089, A47573-090, A47573-091, A47573-092, A47573-093, A47573-094, A47573-095, A47672-060, A47672-061, A47672-062, A47672-063, A47672-064, A47672-065, A47672-066, A47672-067, A47672-068, A47672-069, A47672-070, A47672-071, A47672-072, A47672-073, A47672-074, A47672-075, A47672-076, A47672-077, A47672-078, A47672-079, A47672-080, A47672-081, A47672-082, A47672-083, A47672-084, A47672-085, A47672-086, A47672-087, A47672-088, A47672-089, A47672-090, A47672-091, A47672-092, A47672-093, A47672-094, A48441-046, A48441-047, A48441-048, A48441-049, A48441-050, A48441-051, A48441-052, A48441-053, A48441-054, A48441-055, A48441-056, A48441-057, A48441-058, A48441-059, A48441-060, A48441-061, A48441-062, A48441-063, A48441-064, A48441-065, A48441-066, A48441-067, A48441-068, A48441-069, A48441-070, A48441-071, A48441-072, A48441-073, A48441-074, A48441-075, A48441-076, A48441-077, A48441-078, A48441-079, A48441-080, A48441-081, A48441-082, A48441-083, A48441-084, A48441-085, A48441-086, A48441-087, A48441-088, A48441-089, A48441-090, A48441-091, A48538-115, A48538-116, A48538-117, A48538-118, A48538-119, A48538-120, A48538-121, A48538-122, A48538-123, A48538-124, A48538-125, A48538-126, A48538-127, A48538-128, A48538-129, A48538-130, A48538-131, A48538-132, A48538-133, A48538-134, A48538-135, A48538-136, A48538-137, A48538-138, A48538-139, A48538-140, A48538-141, A48538-142, A48538-143, A48538-144, A48538-145, A48538-146, A48538-147, A48538-148, A48538-149, A48538-150, A49912-056, A49912-057, A49912-058, A49912-059, A49912-060, A49912-061, A49912-062, A49912-063, A49912-064, A49912-065, A49912-066, A49912-067, A49912-068, A49912-069, A49912-070, A49912-071, A49912-072, A49912-073, A49912-074, A49912-075, A49912-076, A49912-077, A49912-078, A49912-079, A49912-080, A49912-081, A49912-082, A49912-083, A49912-084, A49912-085, A49912-086, A49912-087, A49912-088, A49912-089, A49912-090, A49912-091, A49912-092, A49912-093, A49975-051, A49975-052, A49975-053, A49975-054, A49975-055, A49975-056, A49975-057, A49975-058, A49975-059, A49975-060, A49975-061, A49975-062, A49975-063, A49975-064, A49975-065, A49975-066, A49975-067, A49975-068, A49975-069, A49975-070, A49975-071, A49975-072, A49975-073, A49975-074, A49975-075, A49975-076, A49975-077, A49975-078, A49975-079, A52779-011, A52779-012, A52779-013, A52779-014, A52779-015, A52779-016, A52779-017, A52779-018, A52779-019, A52779-020, A52779-021, A52779-022, A52779-023, A53118-021, A53118-022, A53118-023, A53118-024, A53118-025, A53118-026, A53118-027, A53118-028, A53118-029, A53118-030, A53118-031, A53118-032, A53118-033, A53118-034, A53118-035, A53118-036, A53118-037, A53118-038, A53118-039, A53118-040, A53118-041, A53118-042, A53118-043, A53118-044, A53118-045, A53118-046, A53118-047, A53118-048, A53118-049, A53118-050, A53118-051, A53118-052, A53118-053, A53118-054, A53118-055, A53118-056, A53118-057, A53118-058, A53118-059, A53118-060, A53118-061, A53118-062, A53118-063, A53118-064, A53118-065, A53118-066, A53118-067, A53118-068, A53118-069, A53118-070, A53118-071, A53118-072, A53118-073, A53118-074, A53118-075, A53118-076, A53118-077, A53118-078, A53118-079, A53118-080, A53118-081, A53177-011, A53177-012, A53177-013, A53177-014, A53177-015, A53177-016, A53177-017, A53177-018, A53177-019, A53177-020, A53177-021, A53177-022, A53177-023, A53177-024, A53177-025, A53177-026, A54244-064, A54244-065, A54244-066, A54244-067, A54244-068, A54244-069, A54244-070, A54244-071, A54244-072, A54244-073, A54350-034, A54350-035, A54350-036, A54350-037, A54350-038, A54350-039, A54350-040, A54350-041, A54350-042, A54350-043, A54350-044, A54350-045, A54350-067, A54350-068, A54350-069, A54350-070; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT, GTIN 00643169964839, Serial Numbers: A37724-094, A37724-095, A37724-096, A37724-097, A37724-098, A37724-099, A37724-100, A37724-101, A37724-102, A37724-103, A37724-104, A37724-105, A37724-106, A37724-107, A37724-108, A37724-109, A37724-110, A37724-111, A37724-112, A37724-113, A37724-114, A37724-115, A37724-116, A37724-117, A37724-118, A37724-119, A37724-120, A37724-121, A37724-122, A37724-123, A37724-124, A37724-125, A37724-126, A39537-031, A39537-032, A39537-033, A39537-034, A39537-035, A39537-036, A39537-037, A39537-038, A39537-039, A39537-040, A39537-041, A39537-042, A39537-043, A39537-044, A39537-045, A39537-046, A39537-047, A39537-048, A39537-049, A39537-050, A39537-051, A39537-052, A39537-053, A42444-041, A42444-042, A42444-043, A42444-044, A42444-045, A42444-046, A42444-047, A42444-048, A42444-049, A42444-050, A42444-051, A42444-052, A42571-102, A42571-103, A42571-104, A42571-105, A42571-106, A42571-107, A42571-108, A42571-109, A42780-068, A42780-069, A42780-070, A42780-071, A42780-072, A42780-073, A42780-074, A42780-075, A42780-076, A42780-077, A42780-078, A42780-079, A42780-080, A42780-081, A42780-082, A42780-083, A42780-084, A42780-085, A42780-086, A42780-087, A42780-088, A42780-089, A42780-090, A42780-091, A42780-092, A42780-093, A42780-094, A42780-095, A42780-096, A42780-097, A42780-098, A42780-099, A42780-100, A42780-101, A43098-042, A43098-043, A43098-044, A43098-045, A43098-046, A43098-047, A43098-048, A43098-049, A43098-050, A43098-051, A43098-052, A43098-053, A43098-054, A43098-055, A43098-056, A43098-057, A43098-058, A43098-059, A43098-060, A43098-061, A43098-062, A43098-063, A43098-064, A43284-036, A43284-037, A43284-038, A43284-039, A43284-040, A43284-041, A43284-042, A43284-043, A43284-044, A43284-045, A43286-067, A43286-068, A43286-069, A43286-070, A43286-071, A43286-072, A43286-073, A43286-074, A43286-075, A43286-076, A43286-077, A43286-078, A43286-079, A43286-080, A43286-081, A43286-082, A43858-011, A43858-012, A43858-013, A43858-014, A43858-015, A43858-016, A43858-017, A43858-018, A43858-019, A43858-020, A43858-021, A43858-022, A43858-023, A43858-024, A43858-025, A43858-026, A43858-027, A43858-028, A43858-029, A43858-030, A43858-031, A43858-032, A43858-033, A43858-034, A43858-035, A43858-036, A43858-037, A43858-038, A43858-039, A43858-040, A43858-041, A43858-042, A43858-043, A43858-044, A43858-045, A43858-046, A43858-047, A43858-048, A43858-049, A43858-050, A43858-051, A43858-052, A43858-053, A43858-054, A43858-055, A43858-056, A43858-057, A43858-058, A43858-059, A43858-060, A43858-061, A44260-011, A44260-012, A44260-013, A44260-014, A44260-015, A44260-016, A44260-017, A44260-018, A44260-019, A44260-020, A44260-021, A44260-022, A44260-023, A44260-024, A44260-025, A46158-057, A46158-058, A46158-059, A46158-060, A46158-061, A46158-062, A46158-063, A46158-064, A46158-065, A46158-066, A46333-031, A46333-032, A46333-033, A46333-034, A46333-035, A46333-036, A46333-037, A46333-038, A46333-039, A46333-040, A46333-041, A46333-042, A46333-043, A46333-044, A46333-045, A46333-046, A46333-047, A46333-048, A46333-049, A46333-050, A46333-051, A46333-052, A46333-053, A46791-011, A46791-012, A46791-013, A46791-014, A46791-015, A46791-016, A46791-017, A46791-018, A46791-019, A46791-020, A46791-021, A46791-022, A46791-023, A46791-024, A46791-025, A46791-026, A46791-027, A47034-041, A47034-042, A47034-043, A47034-044, A47034-045, A47034-046, A47034-047, A47034-048, A47034-049, A47034-050, A47034-051, A47034-052, A47034-053, A47034-054, A47034-055, A47034-056, A47034-057, A47034-058, A47034-059, A47034-060, A47034-061, A47034-062, A48114-084, A48114-085, A48114-086, A48114-087, A48114-088, A48114-089, A48114-090, A48114-091, A48114-092, A48114-093, A48114-094, A48114-095, A48114-096, A481...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC, REF S41150, GTIN 00613994961143, Serial Numbers: A43939, A47225 c) DBM T41110 0.5CC GRAFTON GEL, REF T41110, GTIN 00643169122956, Serial Numbers: A38528-100, A38528-101, A38528-102, A38528-103, A38528-104, A38528-105, A38528-106, A38910-058, A38910-059, A38910-060, A38910-061, A38910-062, A41224-053, A41224-054, A41224-055, A41224-056, A41224-057, A41224-058, A41224-059, A41224-060, A41224-061, A41224-062, A41224-063, A41224-064, A41224-065, A41224-066, A41224-067, A41224-068, A41224-069, A41224-070, A41224-071, A41224-072, A41935-025, A41935-026, A41935-027, A41935-028, A41935-029, A41935-030, A41935-031, A41935-032, A41935-033, A41935-034, A41935-035, A41935-036, A41935-037, A41935-038, A41935-039, A41935-040, A41935-041, A41935-042, A41935-043, A41935-044, A41935-045, A41935-046, A41935-047, A41935-048, A41935-049, A41935-050, A41935-051, A41935-052, A41935-053, A42221-076, A42221-077, A42221-078, A42221-079, A42221-080, A42221-081, A42221-082, A42221-083, A42221-084, A42221-085, A42619-011, A42619-012, A42619-013, A42619-014, A42619-015, A42619-016, A42619-017, A42619-018, A42619-019, A42619-020, A42619-021, A42619-022, A42619-023, A42619-024, A42619-025, A42619-026, A42619-027, A42619-028, A42619-029, A42619-030, A42619-031, A42619-032, A42619-033, A42619-034, A42619-035, A42619-036, A43231-127, A43231-128, A43286-011, A43286-012, A43286-013, A43286-014, A43286-015, A43286-016, A43286-017, A43286-018, A43286-019, A43286-020, A43286-021, A43286-022, A43286-023, A43286-024, A43286-025, A43286-026, A43286-027, A43286-028, A43286-029, A43286-030, A43286-031, A43286-032, A43286-033, A43286-034, A43286-035, A43286-036, A43286-037, A43286-038, A43286-039, A43286-040, A43286-041, A43286-042, A43286-043, A43286-044, A43286-045, A43286-046, A43286-047, A43286-048, A43286-049, A43286-050, A43286-051, A43286-052, A43286-053, A43286-054, A43286-055, 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A42444-043, A42444-044, A42444-045, A42444-046, A42444-047, A42444-048, A42444-049, A42444-050, A42444-051, A42444-052, A42571-102, A42571-103, A42571-104, A42571-105, A42571-106, A42571-107, A42571-108, A42571-109, A42780-068, A42780-069, A42780-070, A42780-071, A42780-072, A42780-073, A42780-074, A42780-075, A42780-076, A42780-077, A42780-078, A42780-079, A42780-080, A42780-081, A42780-082, A42780-083, A42780-084, A42780-085, A42780-086, A42780-087, A42780-088, A42780-089, A42780-090, A42780-091, A42780-092, A42780-093, A42780-094, A42780-095, A42780-096, A42780-097, A42780-098, A42780-099, A42780-100, A42780-101, A43098-042, A43098-043, A43098-044, A43098-045, A43098-046, A43098-047, A43098-048, A43098-049, A43098-050, A43098-051, A43098-052, A43098-053, A43098-054, A43098-055, A43098-056, A43098-057, A43098-058, A43098-059, A43098-060, A43098-061, A43098-062, A43098-063, A43098-064, A43284-036, A43284-037, A43284-038, A43284-039, A43284-040, A43284-041, A43284-042, A43284-043, A43284-044, A43284-045, A43286-067, A43286-068, A43286-069, A43286-070, A43286-071, A43286-072, A43286-073, A43286-074, A43286-075, A43286-076, A43286-077, A43286-078, A43286-079, A43286-080, A43286-081, A43286-082, A43858-011, A43858-012, A43858-013, A43858-014, A43858-015, A43858-016, A43858-017, A43858-018, A43858-019, A43858-020, A43858-021, A43858-022, A43858-023, A43858-024, A43858-025, A43858-026, A43858-027, A43858-028, A43858-029, A43858-030, A43858-031, A43858-032, A43858-033, A43858-034, A43858-035, A43858-036, A43858-037, A43858-038, A43858-039, A43858-040, A43858-041, A43858-042, A43858-043, A43858-044, A43858-045, A43858-046, A43858-047, A43858-048, A43858-049, A43858-050, A43858-051, A43858-052, A43858-053, A43858-054, A43858-055, A43858-056, A43858-057, A43858-058, A43858-059, A43858-060, A43858-061, A44260-011, A44260-012, A44260-013, A44260-014, A44260-015, A44260-016, A44260-017, A44260-018, A44260-019, A44260-020, A44260-021, A44260-022, A44260-023, A44260-024, A44260-025, A46158-057, A46158-058, A46158-059, A46158-060, A46158-061, A46158-062, A46158-063, A46158-064, A46158-065, A46158-066, A46333-031, A46333-032, A46333-033, A46333-034, A46333-035, A46333-036, A46333-037, A46333-038, A46333-039, A46333-040, A46333-041, A46333-042, A46333-043, A46333-044, A46333-045, A46333-046, A46333-047, A46333-048, A46333-049, A46333-050, A46333-051, A46333-052, A46333-053, A46791-011, A46791-012, A46791-013, A46791-014, A46791-015, A46791-016, A46791-017, A46791-018, A46791-019, A46791-020, A46791-021, A46791-022, A46791-023, A46791-024, A46791-025, A46791-026, A46791-027, A47034-041, A47034-042, A47034-043, A47034-044, A47034-045, A47034-046, A47034-047, A47034-048, A47034-049, A47034-050, A47034-051, A47034-052, A47034-053, A47034-054, A47034-055, A47034-056, A47034-057, A47034-058, A47034-059, A47034-060, A47034-061, A47034-062, A48114-084, A48114-085, A48114-086, A48114-087, A48114-088, A48114-089, A48114-090, A48114-091, A48114-092, A48114-093, A48114-094, A48114-095, A48114-096, A481...

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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