Recall archive / FDA device enforcement
Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT... — FDA record Z-1330-2023
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 DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; 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
- 47436 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1330-2023
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) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038, A40005-039, A40005-040, A40005-041, A40005-042, A40005-043, A40005-045, A40005-046, A40005-047, A40005-048, A40005-049, A40005-051, A40005-053, A40005-054, A40005-055, A40005-056, A40005-057, A40005-058, A40005-059, A40005-060, A40005-061, A40005-062, A40005-063, A40005-064, A40005-065, A40005-066, A40005-067, A40005-068, A40005-069, A40005-070, A40005-071, A40005-072, A40005-073, A40005-074, A40005-075, A40005-076, A40005-077, A40005-078, A40005-079, A40005-080, A40005-081, A40005-082, A40005-083, A40005-084, A40005-085, A40005-086, A40005-087, A40005-088, A40005-089, A40005-090, A40005-091, A40005-092, A40005-093, A40005-094, A40005-095, A40005-096, A40005-097, A40005-098, A40005-099, A40005-100, A40005-101, A40005-102, A40304-210, A40304-211, A40304-212, A40304-213, A40304-214, A40304-215, A40304-216, A40304-217, A40304-218, A40304-219, A40304-220, A40304-221, A40304-222, A40304-223, A40304-224, A40304-225, A40304-226, A40304-227, A40304-228, A40304-229, A40304-230, A40304-231, A40304-232, A40304-233, A40304-234, A40304-235, A40304-236, A40304-237, A40304-238, A40304-239, A40304-240, A40304-241, A40304-242, A40304-243, A40304-244, A40304-245, A40304-246, A40304-247, A40304-248, A40304-249, A40304-250, A40304-251, A40304-252, A40304-253, A40304-254, A40304-255, A40304-256, A40304-258, A40304-259, A40304-260, A40304-261, A40304-262, A40304-263, A40304-264, A40304-265, A40304-266, A40304-267, A40304-268, A40304-269, A40304-270, A40304-271, A40304-272, A40304-273, A40304-274, A40304-275, A40304-276, A40304-277, A40304-278, A40304-279, A40304-280, A41003-085, A41003-086, A41003-087, A41003-088, A41003-089, A41003-090, A41003-091, A41003-092, A41003-093, A41003-094, A41003-095, A41003-096, A41003-097, A41003-098, A41003-099, A41003-100, A41003-101, A41003-102, A41003-103, A41003-104, A41003-105, A41003-106, A41003-107, A41003-109, A41003-110, A41003-111, A41003-112, A41003-113, A41003-114, A41003-115, A41003-117, A41003-118, A41003-119, A41003-120, A41003-121, A41003-122, A41003-125, A41003-126, A41003-127, A41003-128, A41003-129, A41003-130, A41003-131, A41003-132, A41003-133, A41003-134, A41003-135, A41003-136, A41003-137, A41003-138, A41003-139, A41003-140, A41003-141, A41003-142, A41003-143, A41003-144, A41003-145, A41003-146, A41003-147, A41003-148, A41003-149, A41003-150, A41003-151, A41003-152, A41003-153, A41003-154, A41003-155, A41003-156, A41003-157, A41003-158, A41003-159, A41003-160, A41003-161, A41003-162, A41003-163, A41003-164, A41003-165, A41003-166, A41003-167, A41003-168, A41003-169, A41003-170, A41003-171, A41003-172, A41003-173, A41003-174, A41219-016, A41219-017, A41219-018, A41219-019, A41219-020, A41219-021, A41219-022, A41219-023, A41219-024, A41219-025, A41219-026, A41219-027, A41219-028, A41219-029, A41219-030, A41219-031, A41219-032, A41219-033, A41219-034, A41987-061, A41987-062, A41987-063, A41987-064, A41987-065, A41987-066, A41987-067, A41987-068, A41987-069, A41987-070, A41987-071, A41987-072, A41987-073, A41987-074, A41987-075, A41987-076, A41987-077, A41987-078, A41987-079, A41987-080, A41987-081, A41987-082, A41987-083, A41987-084, A41987-085, A41987-086, A41987-087, A41987-088, A41987-089, A41987-090, A41987-091, A41987-092, A41987-093, A41987-094, A41987-095, A41987-096, A41987-097, A41987-098, A41987-099, A41987-100, A41987-101, A41987-102, A41987-103, A41987-104, A41987-105, A41987-106, A41987-107, A41987-108, A41987-109, A41987-110, A41987-111, A41987-112, A41987-113, A41987-114, A41987-115, A41987-116, A41987-117, A41987-118, A41987-119, A41987-120, A41987-121, A41987-122, A41987-123, A41987-124, A41987-125, A42558-037, A42558-038, A42558-039, A42558-040, A42558-041, A42558-042, A42558-043, A42558-044, A42558-045, A42558-046, A42558-047, A42558-048, A42558-049, A42558-050, A42558-051, A42558-052, A42558-053, A42558-054, A42558-055, A42558-056, A42558-057, A42558-058, A42558-059, A42558-060, A42558-061, A42558-062, A42558-063, A42558-064, A42558-065, A42558-066, A42558-067, A42558-068, A42558-069, A42558-070, A42558-071, A42558-072, A42558-073, A42558-074, A42558-075, A42558-076, A42558-077, A42558-078, A42558-079, A42558-080, A42558-081, A42558-082, A42558-083, A42558-084, A42558-085, A42558-086, A42558-087, A42558-088, A42558-089, A42558-090, A42558-091, A42558-092, A42558-093, A42558-094, A42558-095, A42558-096, A42558-097, A42558-098, A42558-099, A42558-100, A42558-101, A42558-102, A42558-103, A42558-104, A42558-105, A42558-106, A42558-107, A42558-108, A42558-109, A42558-110, A42558-111, A42558-112, A42558-113, A42558-114, A42558-115, A42558-116, A42558-117, A42558-118, A42558-119, A42558-120, A42558-121, A42558-122, A42558-123, A42558-124, A42558-125, A42558-126, A42558-127, A42558-128, A42558-129, A42558-130, A42558-131, A42558-132, A42558-133, A42558-134, A42558-135, A42558-136, A42558-137, A42558-138, A42558-139, A42558-140, A42558-141, A42558-142, A42558-143, A42558-144, A42558-145, A42558-146, A42558-147, A42558-148, A42558-149, A42558-150, A42558-151, A42558-152, A42558-153, A42558-154, A42558-155, A42558-156, A42756-032, A42756-033, A42756-034, A42756-035, A42756-036, A42756-037, A42756-038, A42756-039, A42756-040, A42756-041, A42756-042, A42756-043, A42756-044, A42756-045, A42756-046, A42756-047, A42756-048, A42756-049, A42756-050, A42756-051, A42756-052, A42756-053, A42756-054, A42756-055, A42756-056, A42756-057, A42756-058, A42756-059, A42756-060, A42756-061, A42756-062, A42756-063, A42756-064, A42756-065, A42756-066, A42756-067, A42756-068, A42756-069, A42756-070, A42756-071, A42756-072, A42756-073, A42756-074, A42756-075, A42756-076, A42756-077, A42756-078, A42756-079, A42756-080, A42756-081, A42756-082, A42756-083, A42756-084, A42756-085, A42756-086, A42756-087, A42756-088, A42756-089, A42756-090, A42756-091, A42756-092, A42756-093, A42756-094, A42756-095, A42756-096, A42756-097, A42756-098, A42756-099, A42756-100, A42756-101, A42756-102, A42756-103, A42756-104, A42756-105, A42756-106, A42756-107, A42756-108, A42874-031, A42874-032, A42874-033, A42874-034, A42874-035, A42874-036, A42874-037, A42874-038, A42874-039, A42874-040, A42874-041, A42874-042, A42874-043, A42874-044, A42874-045, A42874-046, A42874-047, A42874-048, A42874-049, A42874-050, A42874-051, A42874-052, A42874-053, A42874-054, A42874-055, A42874-056, A42874-057, A42874-058, A42874-059, A42874-060, A42874-061, A42874-062, A42874-063, A42874-064, A42874-065, A42874-066, A42874-067, A42874-068, A42874-069, A42874-070, A42874-071, A42874-072, A42874-073, A42874-074, A42874-075, A42874-076, A42874-077, A42874-078, A42874-079, A42874-080, A42874-081, A42874-082, A42874-083, A42874-084, A42874-085, A42874-086, A42874-087, A42874-088, A42874-089, A42874-090, A42874-091, A42874-092, A42874-093, A42874-094, A42874-095, A42874-096, A42874-097, A42874-098, A42874-099, A42874-100, A42874-101, A42874-102, A42874-103, A42874-104, A42874-105, A42874-106, A42874-107, A42874-108, A42874-109, A42874-110, A42874-111, A42874-112, A42874-113, A42874-114, A42874-115, A42874-116, A42874-117, A42874-118, A42874-119, A42874-120, A42874-121, A42874-122, A42874-123, A42874-124, A42874-125, A42874-126, A42874-127, A42874-128, A42874-129, A42874-130, A42874-131, A42874-133, A42874-134, A42874-135, A42874-136, A42874-137, A42874-138, A42874-139, A42874-140, A42874-141, A42874-142, A42874-143, A42874-144, A42874-145, A42874-146, A42874-147, A42965-079, A42965-080, A42965-081, A42965-084, A42965-085, A42965-086, A42965-087, A42965-089, A42965-090, A42965-091, A42965-092, A42965-093, A42965-094, A42965-095, A42965-096, A42965-097, A42965-098, A42965-099, A42965-100, A42965-101, A42965-102, A42965-103, A42965-104, A42965-105, A42965-106, A42965-107, A42965-108, A42965-109, A42965-110, A42965-111, A42965-112, A42965-113, A42965-114, A42965-115, A42965-116, A42965-117, A42965-118, A42965-119, A42965-120, A42965-121, A42965-122, A42965-123, A42965-124, A42965-125, A42965-126, A42965-127, A42965-129, A42965-130, A42965-131, A42965-132, A42965-133, A42965-134, A42965-135, A42965-136, A42965-137, A42965-138, A42965-139, A42965-140, A42965-141, A42965-142, A42965-143, A42965-144, A42965-145, A42965-146, A42965-148, A42965-149, A42965-150, A42965-151, A42965-152, A42965-153, A42965-154, A42965-155, A42965-156, A42965-157, A42965-158, A42965-159, A42965-160, A42965-161, A42965-162, A43023-045, A43023-046, A43023-047, A43023-048, A43023-049, A43023-050, A43023-051, A43023-052, A43023-053, A43023-054, A43023-055, A43023-056, A43023-057, A43023-058, A43023-059, A43023-060, A43023-061, A43023-062, A43023-063, A43023-064, A43023-065, A43023-066, A43023-067, A43023-068, A43023-069, A43023-070, A43023-071, A43023-072, A43023-073, A43023-074, A43023-075, A43023-076, A43023-077, A43023-078, A43023-079, A43023-080, A43023-081, A43023-082, A43023-083, A43023-084, A43023-085, A43023-086, A43023-087, A43023-088, A43023-089, A43023-090, A43023-091, A43023-092, A43023-093, A43023-094, A43023-095, A43023-096, A43023-097, A43023-098, A43023-099, A43023-100, A43023-101, A43023-102, A43023-103, A43023-104, A43023-105, A43023-106, A43023-107, A43023-108, A43023-109, A43023-110, A43023-111, A43023-112, A43023-113, A43023-114, A43023-115, A43023-116, A43023-117, A43023-118, A43023-119, A43023-120, A43023-121, A43023-122, A43023-123, A43023-124, A43023-125, A43023-126, A43023-127, A43023-128, A43023-129, A43023-130, A43023-131, A43023-132, A43023-133, A43023-134, A43023-135, A43023-136, A43023-137, A43023-138, A43023-139, A43023-140, A43023-141, A43023-142, A43023-143, A43023-144, A43023-145, A43023-146, A43023-147, A43023-148, A43023-149, A43023-150, A43023-151, A43023-152, A43023-153, A43023-154, A43023-155, A43023-156, A43023-157, A43023-158, A43023-159, A43023-160, A43023-161, A43023-162, A43023-163, A43023-164, A43023-165, A43023-166, A43023-167, A43023-168, A43023-169, A43023-170, A43633-036, A43633-037, A43633-038, A43633-039, A43633-040, A43633-041, A43633-042, A43633-043, A43633-044, A43633-045, A43633-046, A43633-047, A43633-048, A43633-049, A43633-050, A43633-051, A43633-052, A43633-053, A43633-054, A43633-055, A43633-056, A43633-057, A43633-058, A43633-059, A43633-060, A43633-061, A43633-062, A43633-063, A43633-064, A43633-065, A43633-066, A43633-067, A43633-068, A43633-069, A43633-070, A43633-071, A43633-072, A43633-073, A43633-074, A43633-075, A43633-076, A43633-077, A43633-078, A43633-079, A43633-080, A43633-081, A43633-082, A43633-083, A43633-084, A43633-085, A43633-086, A43633-087, A43633-088, A43633-089, A43633-090, A43633-091, A43633-092, A43633-093, A43633-094, A43633-095, A43633-096, A43633-097, A43633-098, A43633-099, A43633-100, A43633-101, A43633-102, A43633-103, A43633-104, A43633-105, A43633-106, A43633-107, A43633-108, A43633-109, A43633-110, A43633-111, A43633-112, A43633-113, A43633-114, A43633-115, A43633-116, A43633-117, A43633-118, A43633-119, A43633-120, A43633-121, A43633-122, A43633-123, A43633-124, A43633-125, A43633-126, A43633-127, A43633-128, A43633-129, A43633-130, A43633-131, A43633-132, A43633-133, A43633-134, A43633-135, A43633-136, A43633-137, A43633-138, A43633-139, A43633-140, A43633-141, A43633-142, A43633-143, A43633-144, A43633-145, A43633-146, A43633-147, A43633-148, A43633-149, A43633-150, A43633-151, A43633-152, A43633-153, A43633-154, A43633-155, A43633-156, A43633-157, A43633-158, A43633-159, A43633-160, A44942-021, A44942-022, A44942-023, A44942-024, A44942-025, A44942-026, A44942-027, A44942-028, A44942-029, A44942-030, A44942-031, A44942-032, A44942-033, A44942-034, A44942-035, A44942-036, A44942-037, A44942-038, A44942-039, A44942-040, A44942-041, A44942-042, A44942-043, A44942-044, A44942-045, A44942-046, A44942-047, A44942-048, A44942-049, A44942-050, A44942-051, A44942-052, A44942-053, A44942-054, A44942-055, A44942-056, A44942-057, A44942-058, A45052-089, A45052-090, A45052-092, A45052-093, A45052-094, A45052-095, A45052-096, A45052-097,... |
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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.