Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT
Medical device recall Z-1326-2023. Published in FDA’s Enforcement Report on Apr 12, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 12, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 30541 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
30541 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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,…
FDA’s list runs to 367,595 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 8, 2023.
- FDA classified it on Apr 4, 2023.
- FDA’s Enforcement Report published it on Apr 12, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Sofamor Danek USA Inc, of Memphis, TN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 367,595 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.