Recall archive / FDA device enforcement

Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LA... — FDA record Z-1326-2023

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 Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT; h) DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF, REF T44135; i) DBM T44135INT 15CC GRAFTON ORTHOBLEND LG, REF T44135INT; j) DBM T44145 5CC ORTHOBLEND SMALL DEFGRAFT, REF T44145; k) DBM T44145AUS 5CC GRAFTON ORTHOBLEND SM, REF T44145AUS; l) DBM T44145INT 5CC GRAFTON ORTHOBLEND SM, REF T44145INT; m) DBM T44150 10CC ORTHOBLEND SMALL DEFGRAF, REF T44150; n) DBM T44150AUS 10CC GRAFTON ORTHOBLEND SM, REF T44150AUS; o) DBM T44150INT 10CC GRAFTON ORTHOBLEND SM, REF T44150INT; 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: 30541 units
Agency-reported status: Ongoing
Source record identifier: Z-1326-2023

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 S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125, GTIN 00613994961075, Serial Numbers: A47433, A48675; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135, GTIN 00613994961068, Serial Numbers: A42664; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145, GTIN 00613994961051, Serial Numbers: A40910, A48944, A52283; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150, GTIN 00613994961044, Serial Numbers: A43743; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125, GTIN 00643169122901, Serial Numbers: A41627-069, A41627-070, A41627-071, A41627-072, A41627-073, A41627-074, A41627-076, A41627-077, A41627-078, A41627-079, A41627-080, A41627-081, A41627-083, A41627-085, A41627-087, A41627-088, A41627-089, A41627-092, A41627-093, A41627-094, A41627-095, A41755-053, A41755-054, A41755-055, A41755-056, A41755-057, A41755-058, A41755-059, A41755-060, A41755-061, A41755-062, A41755-063, A41755-064, A41755-065, A41755-066, A41755-067, A41755-068, A41755-071, A41755-072, A41755-073, A41755-074, A41755-076, A41755-077, A41755-078, A41755-079, A41755-082, A41755-083, A41755-084, A41755-085, A41755-086, A41755-087, A41755-088, A41755-089, A41755-090, A41755-091, A41755-092, A41755-093, A41755-094, A41755-095, A41755-096, A41755-097, A41755-098, A41755-099, A41755-100, A41755-101, A41755-102, A41755-103, A41755-104, A41755-105, A41755-106, A41755-107, A41755-108, A41755-109, A41755-110, A41755-111, A41755-112, A41755-113, A41755-114, A41755-115, A41755-116, A41755-117, A41755-118, A41755-119, A41755-120, A41755-121, A41755-122, A41755-123, A41755-124, A41755-125, A41755-126, A41755-127, A41755-128, A41755-129, A41755-130, A41755-131, A42328-052, A42328-053, A42328-054, A42328-055, A42328-056, A42328-057, A42328-058, A42328-059, A42328-060, A42328-061, A42328-062, A42328-063, A42328-064, A42328-065, A42328-066, A42328-067, A42328-068, A42328-069, A42328-072, A42328-074, A42328-075, A42328-076, A42328-077, A43105-035, A43105-036, A43105-037, A43105-038, A43105-039, A43105-040, A43105-041, A43105-042, A43105-043, A43105-044, A43105-045, A43105-046, A43114-053, A43114-054, A43114-055, A43114-056, A43114-057, A43114-058, A43114-059, A43114-060, A43114-061, A44317-080, A44317-081, A44317-082, A44317-083, A44317-084, A44317-085, A44317-086, A44317-087, A44317-088, A44317-089, A44317-090, A44317-091, A44317-092, A44317-093, A44317-094, A44682-067, A44682-068, A44682-069, A44682-070, A44682-071, A44682-072, A44682-073, A44682-074, A44682-075, A44682-076, A44682-077, A44682-078, A44682-079, A44682-080, A44682-081, A44682-082, A44682-083, A44682-084, A44682-085, A45053-011, A45053-012, A45053-013, A45053-014, A45053-015, A45053-016, A45053-017, A45053-018, A45053-019, A45053-020, A45053-021, A45053-022, A45053-024, A45053-025, A45053-026, A45612-034, A45612-035, A45612-036, A45612-037, A45612-038, A45612-039, A45612-040, A45612-041, A45612-042, A45612-043, A45612-044, A45612-045, A45612-046, A45612-049, A45612-050, A45612-051, A45612-052, A45612-053, A45612-054, A45612-055, A45612-056, A45612-057, A45612-058, A45612-059, A45612-060, A45612-061, A45612-062, A45612-063, A45612-064, A45612-065, A45612-066, A45612-067, A45612-068, A45612-069, A45612-070, A45612-071, A45612-072, A45612-073, A45612-074, A45612-075, A45612-076, A45612-077, A45612-078, A45612-079, A45612-080, A45612-081, A45612-082, A45612-083, A45612-084, A45612-085, A45612-086, A46728-056, A46728-057, A46728-058, A46728-059, A46728-060, A46728-061, A46728-062, A46728-063, A46728-064, A46728-065, A46728-066, A46728-067, A46728-068, A46728-069, A46728-070, A46728-071, A46728-072, A46728-073, A46728-074, A46728-075, A46728-076, A46728-077, A46728-078, A46728-079, A46728-080, A46728-081, A46728-082, A46728-083, A46728-084, A46728-085, A46728-086, A46728-087, A46728-088, A46728-089, A46728-090, A46728-091, A46728-092, A46728-093, A46728-094, A46728-095, A46728-096, A46728-097, A46728-098, A46728-099, A46728-100, A46728-101, A46728-102, A46728-103, A46728-104, A46728-105, A46728-106, A46728-107, A46728-108, A46728-109, A46728-110, A46728-111, A46728-112, A46728-113, A46728-114, A46728-115, A46728-116, A46728-117, A47648-036, A47648-037, A47648-038, A47648-039, A48717-028, A48717-029, A48717-030, A48717-031, A48717-032, A48717-033, A48717-034, A48717-035, A48717-036, A48717-037, A48717-038, A48717-039, A48717-040, A48717-041, A48717-042, A48717-043, A48717-044, A48717-045, A48717-046, A48717-047, A48717-048, A48717-049, A48717-050, A48717-051, A48717-052, A48717-053, A48717-054, A48717-055, A48717-056, A48717-057, A48717-058, A48717-059, A48717-060, A51168-011, A51168-012, A51168-013, A51168-014, A51168-015, A51168-016, A51168-017, A51168-018, A51168-019, A51168-020, A51168-021, A51168-022, A51168-023, A51168-024, A51168-025, A51168-026, A51168-027, A51168-028, A51168-029, A51168-030, A51168-031, A51168-032, A51168-033, A51168-034, A51168-035, A51168-036, A51168-037, A51168-038, A51168-039, A51168-040, A51168-041, A51168-042, A51168-043, A51168-044, A51168-045, A51168-046, A51168-047, A51168-048, A51168-049, A51168-050, A51977-214, A51977-215, A51977-216, A51977-217, A51977-218, A51977-219, A51977-220, A51977-221, A51977-222, A52744-027, A52744-028, A52744-029, A52744-030, A52744-031, A52744-032, A52744-033, A52744-034, A52744-035, A52744-036, A52744-037, A52744-038, A52744-039, A52744-040, A52744-041, A52744-042, A52744-043, A52744-044, A52744-045, A52744-046, A52744-047, A52744-048, A52744-049, A53750-193, A53750-194, A53750-195, A53750-196, A53750-198, A53750-200, A53750-209, A53750-212, A53750-213, A53750-214, A53750-235, A53750-236, A53750-237, A53750-238, A53750-239, A53750-240, A53750-243, A53750-244, A53750-245, A53750-246, A53750-247; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS, GTIN 00643169431027, Serial Numbers: A42115-061, A42115-062, A42115-063, A44487-057, A44487-058, A44487-059, A44487-060, A44487-061, A44487-062, A44487-063, A44487-064, A44487-065, A44487-066, A44487-067, A44487-068, A46117-055, A46117-056, A46117-057, A46117-058, A46117-059, A47598-134, A47598-135, A47598-136, A47598-138, A47598-139, A47598-140, A47598-141, A47598-142, A47598-143, A49862-054, A49862-055; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT, GTIN 00643169965058, Serial Numbers: A38959-090, A38959-091, A38959-092, A38959-093, A38959-094, A38959-095, A38959-096, A38959-097, A38959-098, A38959-099, A38959-100, A38959-101, A38959-102, A38959-103, A38959-104, A38959-105, A38959-106, A38959-107, A38959-108, A38959-109, A38959-110, A38959-111, A38959-112, A40657-034, A40657-035, A40657-036, A40657-037, A40657-038, A40657-039, A40657-040, A40657-041, A40657-042, A40657-043, A40657-044, A40657-045, A40657-046, A40657-047, A40657-048, A40657-049, A40657-050, A40657-051, A40657-052, A40657-053, A40657-054, A40657-055, A40657-056, A40657-057, A40657-058, A40657-059, A40657-060, A40657-061, A40657-062, A40657-063, A40657-064, A40657-065, A40657-066, A40657-067, A40657-068, A40657-069, A40657-070, A40657-071, A40657-072, A40657-073, A40657-074, A40657-075, A40657-076, A40657-077, A40657-078, A40657-079, A40657-080, A40657-081, A40657-082, A40657-083, A40657-084, A40657-085, A40657-086, A40657-087, A40657-088, A40657-089, A40657-090, A40657-091, A40657-092, A40657-093, A40657-094, A40657-095, A40657-096, A40657-097, A40657-098, A40657-099, A40657-100, A40657-101, A40657-102, A40657-103, A40657-104, A40657-105, A40657-106, A40657-107, A40657-108, A40657-109, A40657-110, A40657-111, A40657-112, A40657-113, A40657-114, A40657-115, A40657-116, A40657-117, A40657-118, A40657-119, A40657-120, A40657-121, A40657-122, A40657-123, A40657-124, A40657-125, A40657-126, A40657-127, A40657-128, A40657-129, A40657-130, A40657-134, A40657-135, A40657-138, A40657-139, A40657-140, A40657-141, A40657-142, A40657-143, A40657-144, A40657-145, A40657-146, A40657-147, A40657-148, A40657-149, A40657-150, A40657-151, A40657-152, A40657-153, A40657-154, A40657-155, A40657-156, A40657-157, A40657-158, A40657-159, A40657-160, A40657-161, A40657-162, A40657-163, A40657-164, A40657-165, A40657-166, A40657-167, A40657-168, A40657-169, A40657-170, A40657-171, A40657-172, A41396-021, A41396-022, A41396-023, A41396-024, A41396-025, A41396-026, A41396-027, A41396-028, A41396-029, A41396-030, A41396-031, A41396-032, A41396-033, A41396-034, A41396-035, A41396-036, A41396-037, A41396-038, A41396-039, A41396-040, A41396-041, A41396-042, A41396-043, A41396-044, A41396-045, A41396-046, A41396-047, A41396-048, A41396-049, A41396-050, A41396-051, A41396-052, A41396-053, A41396-054, A41396-055, A41396-056, A41396-057, A41396-058, A41396-059, A41396-060, A41396-061, A41396-062, A41396-063, A41396-064, A41396-065, A41396-066, A41396-067, A41396-068, A41396-069, A41396-070, A41396-071, A41396-072, A41396-073, A41396-074, A41396-075, A41396-076, A41396-077, A41396-078, A41396-079, A41396-080, A41396-081, A41396-082, A41396-083, A41396-084, A41704-120, A41704-121, A41704-122, A41704-123, A41704-124, A41704-125, A41704-126, A41704-127, A41704-128, A41704-129, A41704-130, A41704-131, A41704-132, A41704-133, A41704-134, A41704-135, A41704-136, A41704-137, A41704-138, A41704-139, A41704-140, A41704-141, A41704-142, A41704-143, A41704-144, A41704-145, A41704-146, A41704-147, A41704-148, A41704-149, A41704-150, A41704-151, A41704-152, A41704-153, A41704-154, A41704-155, A41704-156, A41704-157, A41704-158, A41704-159, A41704-160, A41704-161, A41704-162, A41704-163, A41704-164, A41704-165, A41704-166, A41704-167, A41704-168, A41704-169, A41704-170, A41704-171, A41704-172, A41704-173, A41704-174, A41704-175, A41704-176, A41704-177, A41704-178, A41704-179, A42115-035, A42115-036, A42115-037, A42115-038, A42115-039, A42115-040, A42115-041, A42115-042, A42115-043, A42115-044, A42115-045, A42115-046, A42115-047, A42115-048, A42115-049, A42115-050, A42115-051, A42115-052, A42115-053, A42115-054, A42115-055, A42115-056, A42115-057, A42115-058, A42115-059, A42115-060, A42191-066, A42191-067, A42191-068, A42191-069, A42191-070, A42191-071, A42191-072, A42191-073, A42191-074, A42191-075, A42191-076, A42191-077, A42191-078, A42191-079, A42191-080, A42871-263, A42871-264, A42871-265, A42871-266, A42871-267, A42871-268, A42871-269, A42871-270, A42871-271, A42871-272, A42871-273, A42871-274, A42871-275, A42871-276, A42871-277, A42871-278, A42871-279, A42871-280, A42871-281, A42871-282, A42871-283, A42871-284, A42871-285, A42871-286, A42871-287, A42871-288, A42871-289, A42871-290, A42871-291, A42871-292, A42871-293, A42871-294, A42871-295, A42871-296, A42871-297, A42871-298, A42871-299, A42871-300, A42871-301, A42871-302, A42871-303, A42871-304, A42871-305, A42871-306, A42871-307, A42871-308, A42871-309, A42871-310, A42871-311, A42871-312, A42871-313, A42871-314, A42871-315, A42871-316, A42871-317, A42871-318, A42871-319, A42871-320, A42871-321, A42871-322, A42871-323, A42871-324, A42871-325, A42871-326, A42871-327, A42871-328, A42871-329, A42871-330, A42871-331, A42871-332, A42871-333, A42871-334, A42871-335, A42871-336, A42871-337, A42871-338, A42871-339, A42871-340, A42930-092, A42930-093, A42930-094, A42930-095, A42930-096, A42930-097, A42930-098, A42930-099, A42930-100, A42930-101, A42930-102, A42930-103, A42930-104, A42930-105, A42930-106, A42930-107, A42930-108, A42930-109, A42930-110, A42930-111, A42930-112, A42930-113, A42930-114, A42930-115, A42930-116, A42930-117, A42930-118, A42930-119, A42930-120, A42930-121, A42930-122, A42930-123, A42930-124, A42930-125, A42930-127, A42930-128, A42930-129, A42930-130, A42930-131, A42930-132, A42930-133, A42930-134, A42930-135, A42930-136, A42930-137, A42930-138, A42930-139, A43105-011, A43105-012, A43105-013, A43105-014, A43105-015, A43105-016, A43105-017, A43105-018, A43105-019, A43105-020, A43105-021, A43105-022, A43105-023, A43105-024, A43105-025, A43105-026, A43105-027, A43105-028, A43105-029, A43105-030, A43114-062, A43114-063, A43114-064, A43114-065, A43114-066, A43114-067, A43114-068, A43114-069, A43114-070, A43114-071, A43114-072, A4311...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125, GTIN 00613994961075, Serial Numbers: A47433, A48675; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135, GTIN 00613994961068, Serial Numbers: A42664; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145, GTIN 00613994961051, Serial Numbers: A40910, A48944, A52283; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150, GTIN 00613994961044, Serial Numbers: A43743; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125, GTIN 00643169122901, Serial Numbers: A41627-069, A41627-070, A41627-071, A41627-072, A41627-073, A41627-074, A41627-076, A41627-077, A41627-078, A41627-079, A41627-080, A41627-081, A41627-083, A41627-085, A41627-087, A41627-088, A41627-089, A41627-092, A41627-093, A41627-094, A41627-095, A41755-053, A41755-054, A41755-055, A41755-056, A41755-057, A41755-058, A41755-059, A41755-060, A41755-061, A41755-062, A41755-063, A41755-064, A41755-065, A41755-066, A41755-067, A41755-068, A41755-071, A41755-072, A41755-073, A41755-074, A41755-076, A41755-077, A41755-078, A41755-079, A41755-082, A41755-083, A41755-084, A41755-085, A41755-086, A41755-087, A41755-088, A41755-089, A41755-090, A41755-091, A41755-092, A41755-093, A41755-094, A41755-095, A41755-096, A41755-097, A41755-098, A41755-099, A41755-100, A41755-101, A41755-102, A41755-103, A41755-104, A41755-105, A41755-106, A41755-107, A41755-108, A41755-109, A41755-110, A41755-111, A41755-112, A41755-113, A41755-114, A41755-115, A41755-116, A41755-117, A41755-118, A41755-119, A41755-120, A41755-121, A41755-122, A41755-123, A41755-124, A41755-125, A41755-126, A41755-127, A41755-128, A41755-129, A41755-130, A41755-131, A42328-052, A42328-053, A42328-054, A42328-055, A42328-056, A42328-057, A42328-058, A42328-059, A42328-060, A42328-061, A42328-062, A42328-063, A42328-064, A42328-065, A42328-066, A42328-067, A42328-068, A42328-069, A42328-072, A42328-074, A42328-075, A42328-076, A42328-077, A43105-035, A43105-036, A43105-037, A43105-038, A43105-039, A43105-040, A43105-041, A43105-042, A43105-043, A43105-044, A43105-045, A43105-046, A43114-053, A43114-054, A43114-055, A43114-056, A43114-057, A43114-058, A43114-059, A43114-060, A43114-061, A44317-080, A44317-081, A44317-082, A44317-083, A44317-084, A44317-085, A44317-086, A44317-087, A44317-088, A44317-089, A44317-090, A44317-091, A44317-092, A44317-093, A44317-094, A44682-067, A44682-068, A44682-069, A44682-070, A44682-071, A44682-072, A44682-073, A44682-074, A44682-075, A44682-076, A44682-077, A44682-078, A44682-079, A44682-080, A44682-081, A44682-082, A44682-083, A44682-084, A44682-085, A45053-011, A45053-012, A45053-013, A45053-014, A45053-015, A45053-016, A45053-017, A45053-018, A45053-019, A45053-020, A45053-021, A45053-022, A45053-024, A45053-025, A45053-026, A45612-034, A45612-035, A45612-036, A45612-037, A45612-038, A45612-039, A45612-040, A45612-041, A45612-042, A45612-043, A45612-044, A45612-045, A45612-046, A45612-049, A45612-050, A45612-051, A45612-052, A45612-053, A45612-054, A45612-055, A45612-056, A45612-057, A45612-058, A45612-059, A45612-060, A45612-061, A45612-062, A45612-063, A45612-064, A45612-065, A45612-066, A45612-067, A45612-068, A45612-069, A45612-070, A45612-071, A45612-072, A45612-073, A45612-074, A45612-075, A45612-076, A45612-077, A45612-078, A45612-079, A45612-080, A45612-081, A45612-082, A45612-083, A45612-084, A45612-085, A45612-086, A46728-056, A46728-057, A46728-058, A46728-059, A46728-060, A46728-061, A46728-062, A46728-063, A46728-064, A46728-065, A46728-066, A46728-067, A46728-068, A46728-069, A46728-070, A46728-071, A46728-072, A46728-073, A46728-074, A46728-075, A46728-076, A46728-077, A46728-078, A46728-079, A46728-080, A46728-081, A46728-082, A46728-083, A46728-084, A46728-085, A46728-086, A46728-087, A46728-088, A46728-089, A46728-090, A46728-091, A46728-092, A46728-093, A46728-094, A46728-095, A46728-096, A46728-097, A46728-098, A46728-099, A46728-100, A46728-101, A46728-102, A46728-103, A46728-104, A46728-105, A46728-106, A46728-107, A46728-108, A46728-109, A46728-110, A46728-111, A46728-112, A46728-113, A46728-114, A46728-115, A46728-116, A46728-117, A47648-036, A47648-037, A47648-038, A47648-039, A48717-028, A48717-029, A48717-030, A48717-031, A48717-032, A48717-033, A48717-034, A48717-035, A48717-036, A48717-037, A48717-038, A48717-039, A48717-040, A48717-041, A48717-042, A48717-043, A48717-044, A48717-045, A48717-046, A48717-047, A48717-048, A48717-049, A48717-050, A48717-051, A48717-052, A48717-053, A48717-054, A48717-055, A48717-056, A48717-057, A48717-058, A48717-059, A48717-060, A51168-011, A51168-012, A51168-013, A51168-014, A51168-015, A51168-016, A51168-017, A51168-018, A51168-019, A51168-020, A51168-021, A51168-022, A51168-023, A51168-024, A51168-025, A51168-026, A51168-027, A51168-028, A51168-029, A51168-030, A51168-031, A51168-032, A51168-033, A51168-034, A51168-035, A51168-036, A51168-037, A51168-038, A51168-039, A51168-040, A51168-041, A51168-042, A51168-043, A51168-044, A51168-045, A51168-046, A51168-047, A51168-048, A51168-049, A51168-050, A51977-214, A51977-215, A51977-216, A51977-217, A51977-218, A51977-219, A51977-220, A51977-221, A51977-222, A52744-027, A52744-028, A52744-029, A52744-030, A52744-031, A52744-032, A52744-033, A52744-034, A52744-035, A52744-036, A52744-037, A52744-038, A52744-039, A52744-040, A52744-041, A52744-042, A52744-043, A52744-044, A52744-045, A52744-046, A52744-047, A52744-048, A52744-049, A53750-193, A53750-194, A53750-195, A53750-196, A53750-198, A53750-200, A53750-209, A53750-212, A53750-213, A53750-214, A53750-235, A53750-236, A53750-237, A53750-238, A53750-239, A53750-240, A53750-243, A53750-244, A53750-245, A53750-246, A53750-247; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS, GTIN 00643169431027, Serial Numbers: A42115-061, A42115-062, A42115-063, A44487-057, A44487-058, A44487-059, A44487-060, A44487-061, A44487-062, A44487-063, A44487-064, A44487-065, A44487-066, A44487-067, A44487-068, A46117-055, A46117-056, A46117-057, A46117-058, A46117-059, A47598-134, A47598-135, A47598-136, A47598-138, A47598-139, A47598-140, A47598-141, A47598-142, A47598-143, A49862-054, A49862-055; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT, GTIN 00643169965058, Serial Numbers: A38959-090, A38959-091, A38959-092, A38959-093, A38959-094, A38959-095, A38959-096, A38959-097, A38959-098, A38959-099, A38959-100, A38959-101, A38959-102, A38959-103, A38959-104, A38959-105, A38959-106, A38959-107, A38959-108, A38959-109, A38959-110, A38959-111, A38959-112, A40657-034, A40657-035, A40657-036, A40657-037, A40657-038, A40657-039, A40657-040, A40657-041, A40657-042, A40657-043, A40657-044, A40657-045, A40657-046, A40657-047, A40657-048, A40657-049, A40657-050, A40657-051, A40657-052, A40657-053, A40657-054, A40657-055, A40657-056, A40657-057, A40657-058, A40657-059, A40657-060, A40657-061, A40657-062, A40657-063, A40657-064, A40657-065, A40657-066, A40657-067, A40657-068, A40657-069, A40657-070, A40657-071, A40657-072, A40657-073, A40657-074, A40657-075, A40657-076, A40657-077, A40657-078, A40657-079, A40657-080, A40657-081, A40657-082, A40657-083, A40657-084, A40657-085, A40657-086, A40657-087, A40657-088, A40657-089, A40657-090, A40657-091, A40657-092, A40657-093, A40657-094, A40657-095, A40657-096, A40657-097, A40657-098, A40657-099, A40657-100, A40657-101, A40657-102, A40657-103, A40657-104, A40657-105, A40657-106, A40657-107, A40657-108, A40657-109, A40657-110, A40657-111, A40657-112, A40657-113, A40657-114, A40657-115, A40657-116, A40657-117, A40657-118, A40657-119, A40657-120, A40657-121, A40657-122, A40657-123, A40657-124, A40657-125, A40657-126, A40657-127, A40657-128, A40657-129, A40657-130, A40657-134, A40657-135, A40657-138, A40657-139, A40657-140, A40657-141, A40657-142, A40657-143, A40657-144, A40657-145, A40657-146, A40657-147, A40657-148, A40657-149, A40657-150, A40657-151, A40657-152, A40657-153, A40657-154, A40657-155, A40657-156, A40657-157, A40657-158, A40657-159, A40657-160, A40657-161, A40657-162, A40657-163, A40657-164, A40657-165, A40657-166, A40657-167, A40657-168, A40657-169, A40657-170, A40657-171, A40657-172, A41396-021, A41396-022, A41396-023, A41396-024, A41396-025, A41396-026, A41396-027, A41396-028, A41396-029, A41396-030, A41396-031, A41396-032, A41396-033, A41396-034, A41396-035, A41396-036, A41396-037, A41396-038, A41396-039, A41396-040, A41396-041, A41396-042, A41396-043, A41396-044, A41396-045, A41396-046, A41396-047, A41396-048, A41396-049, A41396-050, A41396-051, A41396-052, A41396-053, A41396-054, A41396-055, A41396-056, A41396-057, A41396-058, A41396-059, A41396-060, A41396-061, A41396-062, A41396-063, A41396-064, A41396-065, A41396-066, A41396-067, A41396-068, A41396-069, A41396-070, A41396-071, A41396-072, A41396-073, A41396-074, A41396-075, A41396-076, A41396-077, A41396-078, A41396-079, A41396-080, A41396-081, A41396-082, A41396-083, A41396-084, A41704-120, A41704-121, A41704-122, A41704-123, A41704-124, A41704-125, A41704-126, A41704-127, A41704-128, A41704-129, A41704-130, A41704-131, A41704-132, A41704-133, A41704-134, A41704-135, A41704-136, A41704-137, A41704-138, A41704-139, A41704-140, A41704-141, A41704-142, A41704-143, A41704-144, A41704-145, A41704-146, A41704-147, A41704-148, A41704-149, A41704-150, A41704-151, A41704-152, A41704-153, A41704-154, A41704-155, A41704-156, A41704-157, A41704-158, A41704-159, A41704-160, A41704-161, A41704-162, A41704-163, A41704-164, A41704-165, A41704-166, A41704-167, A41704-168, A41704-169, A41704-170, A41704-171, A41704-172, A41704-173, A41704-174, A41704-175, A41704-176, A41704-177, A41704-178, A41704-179, A42115-035, A42115-036, A42115-037, A42115-038, A42115-039, A42115-040, A42115-041, A42115-042, A42115-043, A42115-044, A42115-045, A42115-046, A42115-047, A42115-048, A42115-049, A42115-050, A42115-051, A42115-052, A42115-053, A42115-054, A42115-055, A42115-056, A42115-057, A42115-058, A42115-059, A42115-060, A42191-066, A42191-067, A42191-068, A42191-069, A42191-070, A42191-071, A42191-072, A42191-073, A42191-074, A42191-075, A42191-076, A42191-077, A42191-078, A42191-079, A42191-080, A42871-263, A42871-264, A42871-265, A42871-266, A42871-267, A42871-268, A42871-269, A42871-270, A42871-271, A42871-272, A42871-273, A42871-274, A42871-275, A42871-276, A42871-277, A42871-278, A42871-279, A42871-280, A42871-281, A42871-282, A42871-283, A42871-284, A42871-285, A42871-286, A42871-287, A42871-288, A42871-289, A42871-290, A42871-291, A42871-292, A42871-293, A42871-294, A42871-295, A42871-296, A42871-297, A42871-298, A42871-299, A42871-300, A42871-301, A42871-302, A42871-303, A42871-304, A42871-305, A42871-306, A42871-307, A42871-308, A42871-309, A42871-310, A42871-311, A42871-312, A42871-313, A42871-314, A42871-315, A42871-316, A42871-317, A42871-318, A42871-319, A42871-320, A42871-321, A42871-322, A42871-323, A42871-324, A42871-325, A42871-326, A42871-327, A42871-328, A42871-329, A42871-330, A42871-331, A42871-332, A42871-333, A42871-334, A42871-335, A42871-336, A42871-337, A42871-338, A42871-339, A42871-340, A42930-092, A42930-093, A42930-094, A42930-095, A42930-096, A42930-097, A42930-098, A42930-099, A42930-100, A42930-101, A42930-102, A42930-103, A42930-104, A42930-105, A42930-106, A42930-107, A42930-108, A42930-109, A42930-110, A42930-111, A42930-112, A42930-113, A42930-114, A42930-115, A42930-116, A42930-117, A42930-118, A42930-119, A42930-120, A42930-121, A42930-122, A42930-123, A42930-124, A42930-125, A42930-127, A42930-128, A42930-129, A42930-130, A42930-131, A42930-132, A42930-133, A42930-134, A42930-135, A42930-136, A42930-137, A42930-138, A42930-139, A43105-011, A43105-012, A43105-013, A43105-014, A43105-015, A43105-016, A43105-017, A43105-018, A43105-019, A43105-020, A43105-021, A43105-022, A43105-023, A43105-024, A43105-025, A43105-026, A43105-027, A43105-028, A43105-029, A43105-030, A43114-062, A43114-063, A43114-064, A43114-065, A43114-066, A43114-067, A43114-068, A43114-069, A43114-070, A43114-071, A43114-072, A4311...

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

Related records