Recall archive / FDA device enforcement

Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T60... — FDA record Z-1334-2023

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 XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; 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: 4348 units
Agency-reported status: Ongoing
Source record identifier: Z-1334-2023

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 T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, A38618-085, A38618-086, A38618-087, A38618-088, A38618-089, A38618-090, A38618-091, A38618-092, A38618-093, A38618-094, A38618-095, A38618-096, A38618-097, A38618-098, A38618-099, A38618-100, A38618-101, A38618-102, A38618-103, A38618-104, A38618-105, A38618-106, A38618-107, A38618-108, A38618-109, A38618-110, A38618-111, A38618-112, A38618-113, A38618-114, A38618-115, A38618-116, A38618-117, A38618-118, A38618-119, A38618-120, A38618-121, A38618-122, A38618-123, A38618-124, A38618-125, A38618-126, A38618-127, A38618-128, A38618-129, A38618-130, A38618-131, A39566-044, A39566-045, A39566-046, A39566-047, A39566-048, A39566-049, A39566-050, A39566-051, A39566-052, A39566-053, A39566-054, A39566-055, A39566-056, A39566-057, A39566-058, A39566-059, A39566-060, A39566-061, A39566-062, A39566-063, A39566-064, A39566-065, A39566-066, A39566-067, A39566-068, A39566-069, A39566-070, A39566-071, A39566-072, A39566-073, A39566-074, A39566-075, A39566-076, A39566-077, A39566-078, A39566-079, A39566-080, A39566-081, A39566-082, A39566-083, A39566-084, A39566-085, A39566-086, A39566-087, A39566-088, A39566-089, A39566-090, A39566-091, A39566-092, A39566-093, A39566-094, A39566-095, A39566-096, A39566-097, A39566-098, A39566-099, A39566-100, A39566-101, A39566-102, A39566-103, A39566-104, A39566-105, A39566-106, A39566-107, A39566-108, A39566-109, A39566-110, A39566-111, A39566-112, A40105-043, A40105-044, A40105-045, A40105-046, A40105-047, A40105-048, A40105-049, A40105-050, A40105-051, A40105-052, A40105-053, A40105-054, A40105-055, A40105-056, A40105-057, A40105-058, A40105-059, A40105-060, A40105-061, A40105-062, A40105-063, A40105-064, A40105-065, A40105-066, A40105-067, A40105-068, A40105-069, A40105-070, A40105-071, A40105-072, A40105-073, A40105-074, A40105-075, A40105-076, A40105-077, A40105-078, A40105-079, A40105-080, A40105-081, A40105-082, A40734-035, A40734-036, A40734-037, A40734-038, A40734-039, A41315-087, A41315-088, A41315-089, A41315-090, A41315-091, A41315-092, 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A41747-091, A41747-092, A41747-093, A41747-094, A41747-095, A41747-096, A41747-097, A41747-098, A41747-099, A41747-100, A41747-101, A41747-102, A41747-103, A41747-104, A41747-105, A41747-106, A41747-107, A41747-108, A41747-109, A41747-110, A41747-111, A41747-112, A41747-113, A41747-114, A41747-115, A41747-116, A41747-117, A41747-118, A41747-119, A41747-120, A41878-133, A41878-134, A41878-135, A41878-136, A41878-137, A41878-138, A41878-139, A41878-140, A41878-141, A41878-142, A41878-143, A41878-144, A41878-145, A41878-146, A41878-147, A41878-148, A41878-149, A41878-150, A41878-151, A41878-152, A41878-153, A41878-154, A41878-155, A41878-156, A41878-157, A41878-158, A41878-159, A41878-160, A41878-161, A41878-162, A41878-163, A41878-164, A41878-165, A41878-166, A41878-167, A41878-168, A41878-169, A41878-170, A41878-171, A41909-011, A41909-012, A41909-013, A41909-014, A41909-015, A41909-016, A41909-017, A41909-018, A41909-019, A41909-020, A41909-021, A41909-022, A41909-023, A41909-024, 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A41909-108, A41909-109, A41909-110, A41909-111, A41909-112, A41909-113, A41909-114, A41909-115, A41909-116, A41909-117, A41909-118, A41909-119, A41909-120, A41909-121, A41909-122, A41909-123, A41909-124, A41909-125, A41909-126, A41909-127, A41909-128, A41909-129, A41909-130, A41909-131, A41909-132, A41909-133, A41909-134, A41909-135, A41909-136, A41909-137, A41909-138, A41909-139, A41909-140, A41909-141, A41909-142, A41909-143, A41909-144, A41909-145, A41909-146, A41909-147, A41909-148, A41909-149, A41909-150, A41909-151, A41909-152, A42407-077, A42407-078, A42407-079, A42407-080, A42407-081, A42407-082, A42407-083, A42407-084, A42407-085, A42407-086, A42407-087, A42407-088, A42407-089, A42407-090, A42407-091, A42407-092, A42407-093, A42407-094, A42407-095, A42407-096, A42407-097, A42407-098, A42407-099, A42407-100, A42407-101, A42407-102, A42407-103, A42407-104, A42407-105, A42407-106, A42407-107, A42407-108, A42407-109, A42407-110, A42407-111, A42407-112, A42407-113, A42407-114, A42407-115, A42407-116, A42407-117, A42407-118, A42407-119, A42407-120, A42407-121, A42407-122, A42407-123, A42407-124, A42540-118, A42540-119, A42540-120, A42540-121, A42540-122, A42540-123, A42540-124, A42540-125, A42540-126, A42540-127, A42540-128, A42540-129, A42540-130, A42540-131, A42540-132, A42540-133, A42540-134, A42540-135, A42540-136, A42540-137, A42540-138, A42540-139, A42540-140, A42540-141, A42540-142, A42540-143, A42540-144, A42540-145, A42540-146, A42540-147, A42540-148, A42540-149, A42540-150, A42540-151, A42540-152, A42540-153, A42540-154, A42540-155, A42540-156, A42540-157, A42964-039, A42964-040, A42964-041, A42964-042, A42964-043, A42964-044, A42964-045, A42964-046, A42964-047, A42964-048, A42964-049, A42964-050, A42964-051, A42964-052, A42964-053, A42964-054, A42964-055, A42964-056, A42964-057, A42964-058, A42964-059, A42964-060, A42964-061, A42964-062, A42964-063, A42964-064, A42964-065, A42964-066, A42964-067, A42964-068, A42964-069, A42964-070, A42964-071, A42964-072, A42964-073, A42964-074, A42964-075, A42964-076, A42964-077, A42964-078, A42964-079, A42964-080, A42964-081, A42964-082, A42964-083, A42964-084, A42964-085, A42964-086, A42964-087, A42964-088, A42964-089, A42964-090, A42964-091, A42964-092, A42964-093, A42964-094, A42964-095, A42964-096, A42964-097, A42964-098, A42964-099, A42964-100, A42964-101, A42964-102, A42964-103, A42964-104, A42964-105, A42964-106, A42964-107, A42964-108, A42964-109, A42964-110, A42964-111, A43287-038, A43287-039, A43287-040, A43287-041, A43287-042, A43287-043, A43287-044, A43287-045, A43287-046, A43287-047, A43287-048, A43287-049, A43287-050, A43287-051, A43287-052, A43287-053, A43287-054, A43287-055, A43287-056, A43287-057, A43287-058, A43287-059, A43287-060, A43287-062, A43287-063, A43287-064, A43287-065, A43287-066, A43287-067, A43287-068, A43287-069, A43287-070, A43287-071, A43287-072, A43287-073, A43287-074, A43287-075, A43287-076, A43287-077, A43287-078, A43287-079, A43287-080, A43299-037, A43299-038, A43299-039, A43299-040, A43299-041, A43299-042, A43299-043, A43299-044, A43299-045, A43299-046, A43299-047, A43299-048, A43299-049, A43299-050, A43299-051, A43299-052, A43299-053, A43299-054, A43299-055, A43299-056, A43299-057, A43299-058, A43299-059, A43299-060, A43299-061, A43299-062, A43299-063, A43299-064, A43299-065, A43299-066, A43299-067, A43299-068, A43299-069, A43299-070, A43299-071, A43299-072, A43299-073, A43299-074, A43299-075, A43299-076, A43299-077, A43299-078, A43299-079, A43299-080, A43299-081, A43299-082, A43299-083, A43299-084, A43745-076, A43745-077, A43745-078, A43745-079, A43745-080, A43745-081, A43745-082, A43745-083, A43745-084, A43745-085, A43745-086, A43745-087, A43745-088, A43745-089, A43745-090, A43745-091, A43745-092, A43745-093, A43745-094, A43745-095, A43745-096, A43745-097, A43745-098, A43745-099, A43745-100, A43745-101, A43745-102, A43745-103, A43745-104, A43745-105, A43745-106, A43745-107, A43745-108, A43745-109, A43745-110, A43745-111, A43745-112, A43745-113, A43745-114, A43745-115, A43745-116, A43745-117, A43745-118, A43745-119, A43745-120, A43745-121, A43745-122, A43745-123, A43745-124, A43748-041, A43748-042, A43748-043, A43748-044, A43748-045, A43748-046, A43748-047, A43748-048, A43748-049, A43748-050, A43748-051, A43748-052, A43748-053, A43748-054, A43748-055, A43748-056, A43748-057, A43748-058, A43748-059, A43748-060, A43748-061, A43748-062, A43748-063, A43748-064, A43748-065, A43748-066, A43748-067, A43748-068, A43748-069, A43748-070, A43748-071, A43748-072, A43748-073, A43748-074, A43748-075, A43748-076, A43748-077, A43748-078, A43748-079, A43748-080, A43748-081, A43748-082, A43748-083, A43748-084, A43748-085, A43748-086, A43748-087, A43748-088, A43748-089, A43748-090, A43748-091, A43748-092, A43748-093, A43748-094, A43748-095, A43748-096, A43748-097, A43748-098, A43748-099, A43748-100, A43748-101, A43748-102, A43748-103, A43748-104, A43748-105, A43748-106, A43748-107, A43748-108, A43748-109, A43748-110, A43748-111, A43748-112, A43748-113, A43748-114, A43748-115, A43748-116, A43748-117, A43748-118, A43748-119, A43748-120, A43748-121, A43748-122, A43748-123, A43748-124, A43748-125, A43748-126, A43748-127, A43748-128, A43748-129, A43748-130, A43748-131, A43748-132, A43748-133, A43748-134, A43748-135, A45739-141, A45739-142, A45739-143, A45739-144, A45739-145, A45739-146, A45739-147, A45739-148, A45739-149, A45739-150, A45739-151, A45739-152, A45739-153, A45739-154, A45739-155, A45739-156, A45739-157, A45739-158, A45739-159, A45739-160, A45739-161, A45739-162, A45739-163, A45739-164, A45739-165, A45739-166, A45739-167, A45739-168, A45739-169, A45739-170, A45739-171, A45739-172, A45739-173, A45739-174, A45739-175, A45739-176, A45739-177, A45739-178, A45739-179, A45739-180, A45739-181, A45739-182, A45739-183, A45739-184, A45739-185, A45739-186, A45739-187, A45739-188, A45739-189, A45739-190, A45739-191, A46458-049, A46458-050, A46458-051, A46458-052, A46458-053, A46458-054, A46458-055, A46458-056, A46458-057, A46458-058, A46458-059, A46458-060, A46458-061...

Label field

Details supplied by the agency

Lot, code or applicability

a) DBM T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, A38618-085, A38618-086, A38618-087, 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A46458-058, A46458-059, A46458-060, A46458-061...

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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