Drug & Device Safety Atlas
Class II FDA device recall · Z-1326-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information 
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, 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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, 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Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm
Medtronic Sofamor Danek USA Inc
Product type
Devices
Recall number
Z-1326-2023
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Memphis, TN
Recall initiated
2023-02-08

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1326-2023 · Source: openFDA enforcement.